Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE,  CHINA, COLOMBIA, CROATIA (local name:  Hrvatska), CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC  OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NETHERLAND ANTILLES, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA,  SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, AND YEMEN.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5  The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
''Model M3535A: US00100100 to US00552845;  Model M3536A: US00100902 to US00552848;  Model M3536M: US00500002 to US00501201; Model M3536MC: US00500001 to US00500087; Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679;  Model M3536M5: US00500001 to US00552801 Note: Not every serial number within the listed ranges are affected by this Medical Device Correction. Philips HeartStart MRx Monitors/Defibrillators (1) within the identified serial number range AND (2) meeting one or both of the conditions below are affected by the issue.  Condition #1: Device has EtCO2 Option.  Devices with the EtCO2 option are affected. To determine if an MRx has the EtCO2 option, press the Menu Select button to open the Main Menu. Use the Navigation and Menu Select buttons to select Other, followed by Print Device Info. Devices with EtCO2 option have etCO2 printed under Options on the printed strip.    Condition #2: Device has Old Cap Plate.  Devices with a paddle tray or the new cap plate are not affected.  New Cap Plate (NOT affected) positions the handle in the middle of the cap plate and covers the entire top of the MRx.''
MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Product was distributed nationwide, including Puerto Rico,  Product was also distributed to Canada and the Netherlands.  No government or military distribution.
Virbac Animal Health C.E.T. AquaDent Drinking Water Additive, packaged in 500 ml (16.9 fl. oz.) plastic bottles and 2 tsp. / 10 ml foil packets.  No NDC is listed.  Virbac AH Inc., Fort Worth, TX.
Product is being recalled due to a GMP deficiency; raw material used during manufacturing did not conform to USP or NF grade.
Distribution pattern was nationwide, including Puerto Rico.  Foreign distribution was made to Mexico and Taiwan.  There was no military or government distribution.
Virbac Etiderm (Ethyl Lactate 10% w/w) Shampoo for Dogs, Cats and Horses, packaged in 8 oz. (NDC 051311-080-08) and 16 oz. (051311-080-16) plastic bottles.  The responsible name of the label is Virbac, Fort Worth, TX 76161.
Active ingredients failed to meet their stability specifications throughout expiry.  Product failed stability (low potency for ethyl lactate).
Virbac Pyoben Gel (Benzoyl Peroxide 3% w/w) for Dogs, Cats and Horses, packaged in 1 oz. plastic bottles.  NDC 051311-014-30.  The responsible name of the label is Virbac, Fort Worth, TX 76161.
Active ingredients failed to meet their stability specifications throughout expiry.  Product failed stability (high potency for benzoyl peroxide).
Virbac Pyoben Shampoo (Benzoyl Peroxide 3% w/w) for Dogs, Cats and Horses, packaged in 8 oz. (NDC 0151311-012-08) and 16 oz. (NDC 051311-012-16) plastic bottles.  The responsible name of the label is Virbac, Fort Worth, TX 76161.
Active ingredients failed to meet their stability specifications throughout expiry.  Product failed stability (low potency for benzoyl peroxide).
Virbac Resiketochlor (Chlorhexidine Gluconate 2.3% w/w; ketoconazole 1% w/w) Leave-on Lotion for Dogs, Cats and Horses, packaged in 8 oz. plastic bottles. NDC 0151311-780-08.  The responsible name of the label is Virbac, Fort Worth, TX 76161.
Active ingredients failed to meet their stability specifications throughout expiry.  Product failed stability (low potency for chlorhexidine gluconate and ketoconazole).
The recalled product was distributed to CA, GA, IL, MN, PA, NV and NY.
by Nature, Active Defense +, Grain Free, 95% Beef & Beef Liver, Made in New Zealand, Distributed By Kent Pet Group, Inc. 2905 N Hwy 61, Muscatine, IA 52761 USA, UPC 8-40673-10078-8
Analysis of 3 lots of product indicate they may contain more than the labeled amounts of vitamin A, calcium, and phosphorus
by Nature, Active Defense +, Grain Free, 95% Beef, Beef Liver & Chicken, Made in New Zealand, Distributed By Kent Pet Group, Inc. 2905 N Hwy 61, Muscatine, IA 52761 USA, UPC 8-40673-10081-8
by Nature, Active Defense +, Grain Free, 95% Chicken & Venison, Made in New Zealand, Distributed By Kent Pet Group, Inc. 2905 N Hwy 61, Muscatine, IA 52761 USA, UPC 8-40673-10084-9
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil)  3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle.  The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,   The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3))  W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3))  W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20  (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V  2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,  The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized): DHEA (Dehydroepiandrosterone Micronized) : TESTO  (Testosterone Trit) W/V (weight/volume) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,  The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 6.5 : 30: 1.25: 0.25  MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20  (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20  (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume)  4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)  : TESTO (Testosterone USP) : DHEA  (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V  (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume)  1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V  (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 83/17  (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40  MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3)  : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP)  IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3)  4.0MG capsules,  Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3)  : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3)  : PROGESTERONE W/V  (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,   The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) : ESTRADIOL (E2)  (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) W/V (weight/volume) VERSABASE  3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream,  dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes,  Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume)  transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
TRIEST 70/20/10  ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
JD & SN Inc., dba Moses Lake Professional Pharmacy
dispensed or distributed in Oregon and Washington.
Cyclosporin drops, ophthalmic 1%, solution, Rx only, compounded by Moses Lake Pharmacy.
The firm is recalling Cyclosporin drops, ophthalmic 1% due to lack of sterility assurance
Buprenorphine, multidose sterile vial, 03.mg/mL, injectable solution, Rx only, compounded by Moses Lake Pharmacy.
The firm is recalling Buprenorphine, injectable solution, due to lack of sterility assurance
FL, KY, MD, MO, NC, NJ, NY, PA, TX, WI, WV
Misoprostol (F.O.B.) 2 mg/5 mL oral Suspension NDC: 22200899801; Misoprostol (F.O.B) 1.4 mg/10 mL Suspension NDC: 22200894701.
Firm determined that formulation was developed with the intent of using an active pharmaceutical ingredient with a potency of greater than or equal 99%.  However, the active pharmaceutical ingredient used in the formulation acquired from the supplier was a 1% diluted product rendering the finished product as sub-potent.
Misoprostol 30 mL 1.4 mg/10 mL Paste NDC: 22200894630; Misoprostol 30 mL 1.4 mg/mL Paste NDC: 22200880730; Misoprostol 60 mL 1.4 mg/10 mL Paste NDC: 22200893660; Misoprostol 60 mL 1.6 mg/30 mL Paste NDC: 22200579460; Misoprostol 60 mL 1.6 mg/5 mL Paste NDC: 22200617260
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Worldwide Distribution - US including AL, CA, MO and Internationally to Australia, Brazil, Canada, China, Croatia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, Singapore, South Africa and United Arab Emirates.
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany.  Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.
Part Nos 1007.28A0 (Adjustable Positioning Elements and 1007.24F0 (Universal Frame with Adjustable Positioning Elements)
United States (3 sets); Rest of World (47 sets)
Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery.  The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.
Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador,  Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
All lots through Expiration Date 06/01/2018
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
All lots through Expiration Date 04/15/2018
Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
New York, New Jersey, Pennsylvania, Vermont, Massachusetts, Indiana, Ohio, Kentucky, Maryland, Virginia, North Carolina, Florida, Mississippi and Louisiana.
Frozen Corn distributed under the following labels and sizes: (a) WYLWOOD Super Sweet Whole Kernel Corn,  NET WT. 16 OZ (1 LB), UPC 051933002401, DISTR. BY: SAVE-A-LOT FOOD STORES LTD. EARTH CITY, MO 63045;  (b) MARKET BASKET Cut Corn, NET WT. 16 OZ. (1 LB.), UPC 049705693414, Packed Exclusively for: DEMOULAS SUPERMARKETS, INC. Tewksbury, MA 01876; (c) Bountiful Harvest WHOLE KERNEL CUT CORN, NET WT. 40 OZ. (2.5 LBS.), UPC 822486120597, Marketed by: Independent Marketing Alliance Houston, TX 77079; (d) WEST CREEK FROZEN VEGETABLES Cut Corn, NET WT. 2.5 LBS., UPC 00806795285239. --- The product is packed in poly bags.
Codes: (a) Best By June 2017  K51564 and K51574;  (b) Best By June 2017  K51574;   (c) Best By June 2017  K51574;   (d) Best By June 2017  K51574
One code of Wylwood brand Frozen Whole Kernel Corn was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the State of Tennessee.  The firm decided to recall other labels and codes produced the same day as the suspect lot as a precaution.
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE:    TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03;   KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01;   TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09;   PACEMAKER PACK, REF 89-8381.01;
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC:    TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
The Great Gourmet 10/3 oz. Coconut seafood crab cake.
The firm is missing important labeling information for three of its products (The Great Gourmet 10/3 oz. Coconut seafood crab cake, The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp cake and The Great Gourmet 32/1 oz. Cheesy Crab & Bacon Bites). The firms product labels do not list wheat in the ingredients statement or contains statement.   Wheat is an allergen and can be harmful to individuals who are allergic to wheat.    The Great Gourmet 10/3 oz. Coconut seafood crab cake, The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp cake and The Great Gourmet 32/1 oz. Cheesy Crab & Bacon Bites are made by The Great Gourmet, Inc.,  5115 Clark Canning House Road, Federalsburg, Maryland  21632
The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp cake
The Great Gourmet 32/1 oz. Cheesy Crab & Bacon Bites .
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Limited Edition cucumbers were distributed in the states of Alaska, Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Kansas, Kentucky, Louisiana, Mississippi, Minnesota, Montana, New Jersey, New Mexico, Nevada, Oklahoma, Oregon, South Carolina, Texas, and Utah and reached customers through retail, food service companies, wholesalers, and brokers.
5/4 Limited Edition Cucumber Carton, Sizes 24SP, 36/36SP, 48.   These cucumbers are shipped in a black, green, yellow, and craft colored carton which reads Limited Edition Pole Grown Cucumbers.  This variety is often referred to as a Slicer or American cucumber.  It has a dark green color.  It typically has a length of 7 to 10 inches and a diameter of 1.75 to 2.5 inches.
Andrew and Williamson Fresh Produce (A&W) is recalling all cucumbers sold under the Limited Edition label because it may be contaminated with Salmonella.
1 1/9 Bushel Limited Edition Cucumber Carton, Sizes: Plains (60-84 count), Extra Large (48 count), Large (60 count), Super Select (72 count), Super Select Special (84 count).   These cucumbers are shipped in a black, green, yellow, and craft colored carton which reads Limited Edition Pole Grown Cucumbers.  This variety is often referred to as a Slicer or American cucumber.  It has a dark green color.  It typically has a length of 7 to 10 inches and a diameter of 1.75 to 2.5 inches.
Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 16 oz. 8 2 oz. bags, UPC: 6 58324  08400, Best If Used By: 9/21/2015, Packed 6 - 8 unit packages/case;   Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 12 oz., , Best If Used By: 9/21/2015, Packed 6 packages/case;           Produced by: Appeeling Fruit, Dauberville, PA 19533
Appeeling Fruit Inc. in Dauberville, Penn. is voluntarily recalling consumer packages of fresh sliced apples with Best-if-Used-by dates of 09/14/15 and 09/21/15, due to the potential to be contaminated with listeria monocytogenes,
Appeeling Fruit Inc.,Dauberville, PA 19533; Fresh Slices,  Net Wt. 20 # Bulk, Best If Used By: 9/18/2015   Appeeling Fruit Inc., Dauberville, PA 19533 (bulk-packed), 4 CT/3 lb. Sweet Apple Slices Best If Used By: 9/18/2015.  Packed 4 - 3lb boxes/case.
Burger King Crown, Apple Slices, Net Wt. 2 oz., Best If Used By: 9/14/2015; packed 20-2 oz. pouches to a case.   Distributed by: Burger King Corporation, Miami, FL 33126
Snack Fresh, Red  Apple Slices, Net Wt. 2 oz., UPC: 0 74641 00982, Best If Used By: 9/21/2015; Distributed by Country Fresh, LLC. , Houston, TX  77090;    packed 100-2 oz. pouches to a case
Wegman's, Organic Apple Wedges, Net Wt. 12 oz., 6 pouches, UPC: 0 77890 28213, Best If Used By: 9/21/2015;  packed 6 - 12 oz. packages/case;     Wegman's, Apple Edges, Net Wt. 16 oz., 8 pouches, UPC: 0 77890 25018, Best If Used By: 9/21/2015;   packed 6 - 16 oz. packages/case.    Distributed By: Wegman's Food Markets, Inc., Rochester, NY 14603
Appeeling Fruit, Tart Fresh, Apple Edges, Net Wt. 12 oz., UPC: 6 58324 00950, Best if used by: 09/21/2015, packed 6 packages/case.
Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA,  KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia and Australia.
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Distributed to the states of NC, OH, MA, and MO.
Samsung GM60A-40S   Intended for use in generating radiographic images of human anatomy.
When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible.  The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.
Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM.
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD).   Intended to provide defibrillation therapy.
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expected
Blood products, that were stored under incorrect temperatures, were distributed.
Blood product, collected from a donor who had previously tested reactive for Hepatitis C (HCV), was distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, associated with an unacceptable pH, was distributed.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads.  hip prosthesis component.
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
GE Healthcare, Discovery MR750w 3.0T.  Product Usage:  The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging.  The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
GE Healthcare, SIGNA Excite 3.0T.  MR System for use as a diagnostic imaging device.
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device.  It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
Labeling: Wrong Bar Code; bar code incorrectly scans as phenobarbital tablets
Red Blood Cells, collected from a donor who confirmed positive for syphilis, was distributed.
Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump).  Used to pump fluids into a patient in a controlled manner.
The device might fail to detect air in line while infusing the medication Venofer.  This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.
Pacific Healthcare, Inc dba B&B Pharmacy
Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia   Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal.  For dental and restorative procedures.
The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking ''RASH3N'' during manufacturing.
Biomet 3i Narrow Right Angle Square Driver Tip.  Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal.  For dental and restorative procedures.
RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip.  Additionally, the RASQ3N received the RASH3N's laser marking ''RASH3N'' during manufacturing.
Worldwide Distribution.  US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
The C-arm may interfere with the table top under certain circumstances.
Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH,  PA,TX, VA, VT, WA and WI.
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5.   Surgical instrument for knee prosthesis implantation.
Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories.   General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect:  A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage
Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY.
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP).  Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES.  Orthopedic implant.
The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates.  Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.
Worldwide Distribution-US (nationwide) and the countries of  Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
Access CEA Assay, Part No. 33200.  For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA and WI.
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530.   Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
Apheresis Red Blood Cells, Leukocytes Reduced
W1151151796166 (double collection); W115115179806V (double collection)
Apheresis Red Blood Cell products, manufactured with lack of assurance of sterility, were distributed.
Walter Reed National Military Medical Center
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
US ( nationwide) Distribution to the states of :  MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades    Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
It was reported that packaging was not properly sealed.
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of CA, CO, MD, WI, FL, GA, IL, IA, ID, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI, and the countries of Canada, United Kingdom, Saudi Arabia, Jordan, United Arab Emirates, Kuwait, and Costa Rica.
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
Part numbers: 4011015 (22 ga X 1.0  long needle) 4011525 (22 ga X 1.5  long needle) 4011515 (25 ga X 1.0  long needle)  Expiration dates from 10/31/15 to 12/31/17.
Utah Medical is conducting a recall of  Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.
Apheresis product, in which quailty control was not performed on a  leukocyte reduced unit, was distributed.
Blood product, for which the deferral screening process was incorrectly performed, was distributed.
Worldwide Distribution: US (nationwide) and Europe.
CARESCAPE VC150 Vital Signs Monitor   Monitor vital signs in humans
Monitor may shut down unintentionally without restarting.
NovoCut Suture Manager; Ceterix catalog number CTX-001.   General and Plastic Surgery: Intended for use in arthroscopic surgery.
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Georgia Germany Hong Kong Hungary India Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Oman Pakistan Panama Peru Philippines Poland Portugal Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syria Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom and Uruguay. .
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Worldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of  Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Catalog number:  CXI-2.6-18-90-P-NS-ANG  Lot:  5505259  Expiration date:  December 10, 2017    Catalog number:  CXI-4.0-35-90-P-NS-0  Lots:  5505279 and 5505279X  Expiration date:  December 10, 2017
Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed  during processing.
Nationwide Distribution including US: AL, IL, IN, and WI.
Medtronic Perfusion Tubing Packs, Models TL7M64R3,  TL7P17R1 &  HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.
This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle