Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE  19711, UPC 670541599747
The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.
PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE  19711, UPC 670541599822
PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for:  Beta Labs, LTD, Newark, DE  19711, UPC 029882559802
RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA,  Manufactured for:  Beta Labs, LTD, Newark, DE  19711, UPC 029882559819
Lot # 1205128 (90ct Bottle) Expires 12/16
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
All unexpired lots of sterile drug products
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip
Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of cheese dip
French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture of French onion dip
Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dip
Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dip
Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the manufacture of dip
Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the manufacture of dip
Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of  cheese dip
Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture of cheese dip
DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060   UPC: 64258 20110
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
DOS PADRES BRAND; CHIPOTLE QUESO; NET WT. 15.6 oz. (442g); Distributed by; CYCLONE ENTERPRISES; Houston, Texas 77060   UPC: 64258 20120
TRULY TEXAS; CHIPOTLE CON QUESO; Queso With Chipotles; NET WT.; 16 OZ. (453g) and NET WT. 8 OZ. (226g); Distributed by: Double T Gourmet Foods, Inc.; PO Box 1582 Montgomery, TX  77356; Phone 936-582-6798; ww.trulytexasfoods.com   UPC: 90191 00105 (16 oz.)  and UPC: 90191 00129 (8 oz.)
99 cases of 12/16 oz jars  and 279 cases of 12/8 oz jars
SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX 78763
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.
NATIVE TEXAN QUESO; NACHO; Medium; NATIVE TEXAN FOOD Co.; NET WT 16oz 453g 1LB.; NATIVE TEXAN FOOD CO. box 50583, Austin TX 78763  www.NativeTexan1836.com
Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 454g; DISTRIBUTED BY H-E-B CENTRAL MARKET, AUSTIN, TX 78735
Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 453g; DISTRIBUTED BY Native Texan Food Co. Box 50583, Austin 78763 www.NATIVETEXAN1836.com
CRAZY JERRY''S DA BIG CHEESE; NET WT. 16 OZ. ( 1 LB.) 454g; Prepared for Crazy Jerry's Inc. P.O. Box 891 Roswell, GA 30077
VIVITROL (naltrexone for extended-release injectable suspension);  380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.
Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.
Customer complaints for failure to deliver the dose.
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only.  Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN  46060  NDC#: 45183-0234-68.
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only.  Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41.  B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only.  Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060,  NDC#: 45183-0965-70.
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only.  Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN.  NDC: 45183-0105-78.
Medtronic MiniMed Paradigm Insulin Infusion Pumps,    Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754.    MiniMed 530G: MMT-551, and MMT-751     Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
Paradigm: MMT-523NAB, MMT-723KNB,  MMT-523NAH, MMT-723KNH,  MMT -523NAL, MMT-723KNL,  MMT-523NAP, MMT-723KNP,  MMT-523NAS, MMT-723KNS,  MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS.    MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
559,374 units total (444,374 units in US)
Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.
ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546
All codes starting with BIO13 and ending with 269 up to and including 365; All codes starting with BIO14 and ending with 001 up to and including 156
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella Contamination.
ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item number AHM547 and item number BLK622
For 8 oz. & 16 oz., all codes starting with BIO13 and ending with 269 up to and including 365 and all codes starting with BIO14 and ending with 001 up to and including 156. For bulk 50 lb., all lot codes
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is  voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination
ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548
ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb.
For 8 oz. & 16 oz., all codes starting with ASCBO13. For 50 lb., all lot codes.
ORGANIC TRADITIONS ULTIMATE SUPERFOOD TRAILMIX; NET WT. 3.5 oz UPC 854260010701
Central Admixture Pharmacy Services, Inc.
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Non Sterility; microbial contamination identified as Aspergillus species
del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Product was distributed through retail stores in Connecticut, New Jersey and New York
La Finquita Quesito Fresco Campesino / Fresh Farmers Cheese.  The product is packaged in a 14.11oz. plastic container, UPC Code: 0 94922 76809 4
The milk used to manufacture the cheese may be contaminated with peanuts and tree nuts (pistachios).
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Worldwide Distribution - US including the states of  AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test).  Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies).  Clinical laboratory test.
Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.
Blood products, collected from  donors whose health history screening was not adequately performed, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873.  Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Failed Impurity/Degradation Specification; 12-month stability time point
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn   Pediatric Endotracheal Intubation Kit
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder    Pediatric Endotracheal Intubation Kit
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn   Pediatric Endotracheal Intubation Kit
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder   Pediatric Endotracheal Intubation Kit
H4051 Endo Tube Holder, Pedi 2.5mm   Pediatric Endotracheal Intubation Kit
H4052 Endo Tube Holder, Pedi 3.0mm   Pediatric Endotracheal Intubation Kit
Blood product, collected from an ineligible donor, was distributed.
Blood product, collected from a donor who had unsuitable test results, was distributed.
Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.
Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument.  The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
Knee Instrument Fixation Screws: 48MM HEADED SCREW   48MM HEADLESS SCREW  MIS HEADED SCREW, 48MM  MIS HEADLESS SCREW, 48MM
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA  ENDO FEMORAL HEAD 42MM DIA  ENDO FEMORAL HEAD 43MM DIA  ENDO FEMORAL HEAD 44MM DIA  ENDO FEMORAL HEAD 45MM DIA  ENDO FEMORAL HEAD 46MM DIA  ENDO FEMORAL HEAD 47MM DIA  ENDO FEMORAL HEAD 48MM DIA  ENDO FEMORAL HEAD 49MM DIA  ENDO FEMORAL HEAD 50MM DIA  ENDO FEMORAL HEAD 51MM DIA  ENDO FEMORAL HEAD 52MM DIA  ENDO FEMORAL HEAD 53MM DIA  ENDO FEMORAL HEAD 54MM DIA  ENDO FEMORAL HEAD 55MM DIA  ENDO FEMORAL HEAD 57MM DIA  ENDO FEMORAL HEAD 60MM DIA  ENDO FEMORAL HEAD 63MM DIA  ENDO FEM HEAD 41MM  ENDO FEM HEAD 42MM  ENDO FEM HEAD 43MM  ENDO PROS HEAD 44MM  ENDO FEM HEAD 45MM  ENDO FEM HEAD 46MM  ENDO FEM HEAD 47MM  ENDO FEM HEAD 48MM  ENDO FEM HEAD 49MM  ENDO FEM HEAD 50MM  ENDO FEM HEAD 51MM  ENDO FEM HEAD 52MM  ENDO FEM HEAD 53MM  ENDO FEM HEAD 54MM  ENDO FEM HEAD 55MM  ENDO FEM HEAD 57MM  ENDO FEM HEAD 60MM  ENDO FEM HEAD 63MM  UNIPOLAR COMPONENT, 41MM  UNIPOLAR COMPONENT, 42MM  UNIPOLAR COMPONENT, 43MM  UNIPOLAR COMPONENT, 44MM  UNIPOLAR COMPONENT, 45MM  UNIPOLAR COMPONENT, 46MM  UNIPOLAR COMPONENT, 47MM  UNIPOLAR COMPONENT, 48MM  UNIPOLAR COMPONENT, 49MM  UNIPOLAR COMPONENT, 50MM  UNIPOLAR COMPONENT, 51MM  UNIPOLAR COMPONENT, 52MM  UNIPOLAR COMPONENT, 53MM  UNIPOLAR COMPONENT, 54MM  UNIPOLAR COMPONENT, 55MM  UNIPOLAR COMPONENT, 56MM  UNIPOLAR COMPONENT, 57MM  UNIPOLAR COMPONENT, 58MM  UNIPOLAR COMPONENT, 59MM  UNIPOLAR COMPONENT, 60MM
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG  CANN BONE SCREW 7.0X105LG  CANN BONE SCREW 7.0X105LG  CANN BONE SCREW 7.0MMX105MMLG  CANN BONE SCREW 7.0X110LG  CANN BONE SCREW 7.0X110LG  CANN BONE SCREW 7.0MMX110MMLG  CANN BONE SCREW 7.0X115LG  CANN BONE SCREW 7.0X115LG  CANN BONE SCREW 7.0MMX115MMLG  CANN BONE SCREW 7.0X120LG  CANN BONE SCREW 7.0X120LG  CANN BONE SCREW 7.0MMX120MMLG  CANN BONE SCREW 7.0X125LG  CANN BONE SCREW 7.0MMX125MMLG  CANN BONE SCREW 7.0X130LG  CANN BONE SCREW 7.0MMX130MMLG  RECON SCR LGE 5.5MMDX105MM  RECON SCR LGE 5.5MMDX110MM  RECON SCR LGE 5.5MMDX115MM  RECON SCR LGE 5.5MMDX120MM  RECON SCR LGE 5.5MMDX125MM  RECON SCR LGE 5.5MMDX130MM  ITST ANTI-ROT SCR 6.5MMDX105MM  ITST ANTI-ROT SCR 6.5MMDX110MM  PERI.  SCR 3.5MM X105MML  PERI SCR. 6.5MM X 100MM L  PERI SCR. 6.5MM X 140MM L  PERI SCR. 6.5MM X 100MM L  PERI SCR. 6.5MM X 100MM L  3.5MM CORT SCR X 105MM SELFTAP  3.5MM CORT SCR X 110MM SELFTAP  5.5MM X 100MM CANN LKNG SCREW  Z NAIL 6.0 X 105 CANC SCREW PT  Z NAIL 6.0 X 110 CANC SCREW PT  Z NAIL 6.0 X 115 CANC SCREW PT  Z NAIL 6.0 X 120 CANC SCREW PT  Z NAIL 6.0 X 125 CANC SCREW PT  Z NAIL 6.0 X 130 CANC SCREW PT  Z NAIL 6.0 X 135 CANC SCREW PT  Z NAIL 6.0 X 140 CANC SCREW PT  Z NAIL 6.0 X 105 CANC SCREW FA  Z NAIL 6.0 X 110 CANC SCREW FA  Z NAIL 6.0 X 115 CANC SCREW FA  Z NAIL 6.0 X 120 CANC SCREW FA  Z NAIL 6.0 X 125 CANC SCREW FA  Z NAIL 6.0 X 130 CANC SCREW FA  Z NAIL 6.0 X 135 CANC SCREW FA  Z NAIL 6.0 X 140 CANC SCREW FA  Z NAIL 6.0 X 105 CANC SCREW PT  Z NAIL 6.0 X 110 CANC SCREW PT  Z NAIL 6.0 X 115 CANC SCREW PT  Z NAIL 6.0 X 120 CANC SCREW PT  Z NAIL 6.0 X 125 CANC SCREW PT  Z NAIL 6.0 X 130 CANC SCREW PT  Z NAIL 6.0 X 135 CANC SCREW PT  Z NAIL 6.0 X 140 CANC SCREW PT  Z NAIL 6.0 X 105 CANC SCREW FA  Z NAIL 6.0 X 110 CANC SCREW FA  Z NAIL 6.0 X 115CANC SCREW FA  Z NAIL 6.0 X 120CANC SCREW FA  Z NAIL 6.0 X 125 CANC SCREW FA  Z NAIL 6.0 X 130 CANC SCREW FA  Z NAIL 6.0 X 135 CANC SCREW FA  Z NAIL 6.0 X 140 CANC SCREW FA  3.5X105 CORT SCR  3.5 X 105 CORT SCR SELF TAP  3.5X110
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG  TUBE & SCP PLT 90DX205LG  TUBE & SCP PLT 90DX255LG  TUBE & SCP PLT 95DX150LG  TUBE & SCP PLT 95DX205LG  TUBE & SCP PLT 95DX255LG  TUBE&SCP PLT 130DX8H  TUBE&SCP PLT 130DX10H  TUBE&SCP PLT 130DX12H  TUBE&SCP PLT 130DX14H  TUBE&SCP PLT 135DX8H  TUBE&SCP PLT 135DX10H  TUBE&SCP PLT 135DX12H  TUBE&SCP PLT 135DX14H  TUBE&SCP PLT 140DX8H  TUBE&SCP PLT 140DX10H  TUBE&SCP PLT 140DX12H  TUBE&SCP PLT 140DX14H  TUBE&SCP PLT 145DX8H  TUBE&SCP PLT 145DX10H  TUBE&SCP PLT 145DX12H  TUBE&SCP PLT 145DX14H  TUBE&SCP PLT 150DX6H  TUBE&SCP PLT 150DX8H  TUBE&SCP PLT 150DX10H  TUBE&SCP PLT 150DX12H  TUBE&SCP PLT 150DX14H  VERSA-FX II SC TUBE PLT 90DX6H  VERSA-FX II SC TUBE PLT 90DX8H  VERSA-FXII SC TUBE PLT 90DX10H  VERSA-FXII SC TUBE PLT 90DX12H  VERSA-FXII SC TUBE PLT 90DX14H  VERSA-FXII SC TUBE PLT 95DX6H  VERSA-FXII SC TUBE PLT 95DX8H  VERSA-FXII SC TUBE PLT 95DX10H  VERSA-FXII SC TUBE PLT 95DX12H  VERSA-FXII SC TUBE PLT 95DX14H  VERSA-FX KEYLESS 90D X 8HOLE  VERSA-FX KEYLESS 90D X 11HOLE  VERSA-FX KEYLESS 95D X 8HOLE  VERSA-FX KEYLESS 95D X 11HOLE  VERSA-FX KEYLESS 95D X 14HOLE  VERSA-FX II STD TUBE 130DX8H  VERSA-FX II STD TUBE 130DX10H  VERSA-FX II STD TUBE 130DX12H  VERSA-FX II STD TUBE 130DX14H  VERSA-FX II STD TUBE 135DX8H  VERSA-FX II STD TUBE 135DX10H  VERSA-FX II STD TUBE 135DX12H  VERSA-FX II STD TUBE 135DX14H  VERSA-FX II STD TUBE 140DX8H  VERSA-FX II STD TUBE 140DX10H  VERSA-FX II STD TUBE 140DX12H  VERSA-FX II STD TUBE 140DX14H  VERSA-FX II STD TUBE 145DX8H  VERSA-FX II STD TUBE 145DX10H  VERSA-FX II STD TUBE 145DX12H  VERSA-FX II STD TUBE 145DX14H  VERSA-FX II STD TUBE 150DX8H  VERSA-FX II STD TUBE 150DX10H  VERSA-FX II STD TUBE 150DX12H  VERSA-FX II STD TUBE 150DX14H  VERSA-FX II KEYLESS TB 130DX8H  VERSA-FX II KEYLESS TB 135DX8H  VERSA-FX II KEYLESS TB 140DX8H  VERSA-FX II KEYLESS TB 145DX8H  VERSA-FX II KEYLESS TB 150DX8H  VERSA-FX KEYLESS 90D X 8HOLE  VERSA-FX KEYLESS 90D X 11HOLE  VERSA-FX KEYLESS 95D X 8HOLE  VERSA-FX KEYLESS 95D X 11HOLE  VERSA-FX KEYLESS 95
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST  FNSTRD HIP 40HDX127ST  FNSTRD HIP 41HDX127ST  FNSTRD HIP 42HDX127ST  FNSTRD HIP 43HDX127ST  FNSTRD HIP 44HDX127ST  FNSTRD HIP 45HDX140ST  FNSTRD HIP 46HDX140ST  FNSTRD HIP 47HDX140ST  FNSTRD HIP 48HDX140ST  FNSTRD HIP 49HDX140ST  FNSTRD HIP 50HDX152ST  FNSTRD HIP 51HDX152ST  FNSTRD HIP 52HDX152ST  FNSTRD HIP 53HDX152ST  FNSTRD HIP 54HDX152ST  FNSTRD HIP 55HDX152ST  FNSTRD HIP 57HDX152ST  FNSTRD HIP 60HDX152ST  FNSTRD HIP 63HDX152ST  FNSTRD HIP 38HDX140ST  FNSTRD HIP 40HDX140ST  FNSTRD HIP 41HDX140ST  FNSTRD HIP 42HDX140ST  FNSTRD HIP 43HDX140ST  FNSTRD HIP 44HDX140ST  FNSTRD HIP 45HDX152ST  FNSTRD HIP 46HDX152ST  FNSTRD HIP 47HDX152ST  FNSTRD HIP 48HDX152ST  FNSTRD HIP 49HDX152ST  FNSTRD HIP 50HDX152ST  FNSTRD HIP 51HDX152ST  HIP PROS 38HDX105ST  HIP PROS 40HDX105ST  HIP PROS 41HDX105ST  HIP PROS 42HDX105ST  HIP PROS 43HDX105ST  HIP PROS 44HDX105ST  HIP PROS 45HDX105ST  HIP PROS 46HDX105ST  HIP PROS 47HDX105ST  HIP PROS 48HDX105ST  HIP PROS 49HDX105ST  HIP PROS 50HDX105ST  HIP PROS 51HDX105ST  HIP PROS 52HDX105ST  HIP PROS 53HDX105ST  HIP PROS 54HDX105ST  HIP PROS 55HDX105ST  HIP PROS 57HDX105ST  HIP PROS 60HDX105ST  HIP PROS 63HDX105ST  FNSTRD HIP 38HDX165ST  FNSTRD HIP 40DX165ST  FNSTRD HIP 41HDX165ST  FNSTRD HIP 42HDX165ST  FNSTRD HIP 43HDX165ST  FNSTRD HIP 44HDX165ST  FNSTRD HIP 45HDX165ST  FNSTRD HIP 46HDX165ST  FNSTRD HIP 47HDX165ST  FNSTRD HIP 48HDX165ST  FNSTRD HIP 49HDX165ST  FNSTRD HIP 50HDX191ST  FNSTRD HIP 51HDX191ST  FNSTRD HIP 52HDX191ST  FNSTRD HIP 53HDX191ST  FNSTRD HIP 54HDX191ST  FNSTRD HIP 55HDX191ST  FNSTRD HIP 57HDX191ST  FNSTRD HIP 60HDX191ST  FNSTRD HIP 63HDX191ST  FNSTRD HIP 38HDX165ST  FNSTRD HIP 41HDX165ST  FNSTRD HIP 43HDX165ST  FNSTRD HIP 44HDX165ST  FNSTRD HIP 46HDX165ST  FNSTRD HIP 48HDX165ST  FNSTRD HIP 49HDX165ST  FNSTRD HIP 51HDX165ST  HIP PROS 38HDX127ST  HIP PROS 40HDX127ST  HIP PROS 41HDX127ST  HIP PROS 42HDX127ST  HIP PROS 43HDX127ST  HIP PROS 44HDX127ST  HIP PROS 45HDX140ST  HIP PROS 46HDX140ST  HIP PROS 47HDX140ST  HIP PR
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM  STEM IMPLANT 22MMDX145MM  STEM IMPLANT 24MMDX145MM  SHARP FLUTED ST 20MMDX75MM  SHARP FLUTED ST 22MMDX75MM  SHARP FLTD ST 24MMDX75MM  SHARP FLUTED ST 20MMDX130MM  SHARP FLUTED ST 22MMDX130MM  SHARP FLUTED ST 24MMDX130MM  CEMENTED STEM EXT 13MM X 145MM  IMPACTOR SLEEVE*  NGK STEM EXT 12X245MM (200MM)  NGK STEM EXT 13X245MM (200MM)  NGK STEM EXT 14X245MM (200MM)  NGK STEM EXT 15X245MM (200MM)  NGK STEM EXT 16X245MM (200MM)  NGK STEM EXT 17X245MM (200MM)  NGK STEM EXT 18X245MM (200MM)  NGK STEM EXT 20X245MM (200MM)  NGK STEM EXT 22X245MM (200MM)  SMOOTH REV STM 9.5MM X 19  SMOOTH REV STM 11.5MM X 1  SMOOTH REV STM 13.5MM X 1  SMOOTH REV STM 15.5MM X 1  SMOOTH REV STM 17.5MM X 1  REV FEM STM 10.5MM X 200M  REV FEM STM 12.5MM X 200M  REV FEM STM 14.5MM X 200M  REV FEM STM 16.5MM X 200M  18.5X200MM REV STEM  REV FEM STM 10.5MM X 250M  REV FEM STM 12.5MM X 250M  REV FEM STM 14.5MM X 250M  REV FEM STM 16.5MM X 250M  12.5X155MM FLUTED OFFST R  14.5X155MM FLUTED OFFST R  16.5X155MM FLUTED OFFST R  18.5X155MM FLUTED OFFST R  20.5X155MM FLUTED OFFST R  12.5X175MM FLUTED REV STM  FLUTE REV STEM - 14.5MM X  FLUTE REV STEM - 16.5MM X  FLUTE REV STEM - 18.5MM X  FLUTE REV STEM - 20.5MM X  FLUTE REV STEM - 22.5MM X  FLUTED REV STM 10.5MM X 1  FLUTED REV STM 11.5MM X 1  FLUTED REV STM 12.5MM X 1  FLUTED REV STM 13.5MM X 1  FLUTED REV STM 14.5MM X 1  FLUTED REV STM 16.5MM X 1  FLUTED REV STM 18.5MM X 1
Blood and Blood Products for Reprocessing
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, in which an antibody identified was labeled and distributed without antibody documented on final label, was distributed.
Blood product, collected from a donor that was missing or incorrectly identified on deferral list who should have been deferred due to history, was distributed.
Northern Illinois Blood Bank dba Rock River Valley BC
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Worldwide Distribution - USA including Puerto Rico and the states of  AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC,  ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV,  WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
Cordis EMPIRA NC RX PTCA Dilatation Catheter
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover.  This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Cordis EMPIRA RX PTCA Dilatation Catheter
Blood product, collected from a donor with a  reported post donation illness, was distributed.
Nationwide and internationally, including Canada and Mexico
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928,  10486890, 10472176, 10639337, and 10639338.
Shoprite Spring Water Net 1 GAL (120 Fl Oz.) 3.78L Distributed by Wakefern Food Corp Elizabeth, NJ Made in USA  UPC 041190007196
Spring Water was found to be positive for E. Coli bacteria.
PriceRite Spring Water Net 1 GAL (3.78 L) Distributed by P.R.R.C. Inc. 5000 Riverside Drive Keasby, NJ 00832  UPC 041190755189
Misbranded Red Blood Cell was distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Misbranded Red Blood Cells were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
GA, NH, CT, IA, PA, WA, IN, TX OH, AZ, FL, MD
Rising Moon Organics Butternut Squash Ravioli,  Organic, Vegetarian & Delicious;        Keep Frozen;  Net Wt. 8 oz.  UPC: 7-85030-55557-6.    Manufactured for Rising Moon Organics.  Manufactured by: Carmel Food Group,  Hayward, CA
Sell by APR 09 2015; Product code 55557.
Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package.
Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internationally to: Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box.    The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.
696 devices total distribution (671 nationwide)
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
Blood product, for which donor eligibility was not complete, was distributed.
Walter L. Shepeard Community Blood Center, Inc.
Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left.  Knee prosthesis.
Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.
Product was distributed to processors and retail outlets in Oregon, Washington, and California.
Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags.  Five pound bags are labeled in part ''OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401 Certified Organic by Oregon Dept. of Agriculture***'', with the lot number applied with a stick-on label.  The twenty pound supplier case is labeled in part, ''***Sunfood SUPERFOODS RAW ORGANIC CAROB POWDER***NET WT. 9 kg (19.8lb)***Distributed by Sunfood 1830 Gillespie Way, Suite 101 El Cajon, CA 92020 USA***''.  UPC code 803813-04429 8.
Hummingbird Wholesale was notified by their Organic Carob Powder supplier of the voluntary recall of this product due to potential Salmonella contamination.
Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO.   The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor,  MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor;  CLASSIFICATION NAME:  Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
The firm became aware of a potential problem that was initiated by a customer complaint.  After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor.  This change to the resistor was a planned change to address a product improvement (improve battery drain).  However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
Product is sold through multi-level marketing.
RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement
RegeneSlim was found to contain DMAA by FDA analysis.
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut,  Macadamia Nut, Mint Crunch    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
4 pack box UPC 011386711558   No lot codes or expiry dates    All individual truffles have the same UPC number so I made them one product..
Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.
Tiny Isle Chocolate Truffles: Gluten-Free, Raw, Vegan, Flavor varieties: Kauai Coconut, Mac Nut, Sea Salt, Mint Crunch, Spicy Lava. 1-oz    Tiny Isle  4504 Kukui St, 20A  Kapaa, HI 96746
Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt.  Keep cold.    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
UPC 011386071157No lot codes or expiry dates
Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,coconut, vanilla, sea salt.  Keep cold.    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
UPC 011386711909; No lot codes or expiry dates
Tiny Isle Mac Nut  Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts,  vanilla, sea salt.  Keep cold.    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
UPC 011386071188; No lot codes or expiry dates
Tiny Isle Mint Crunch   Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder cacao nibs, mint,   sea salt.  Keep cold.    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
UPC 011386071164; No lot codes or expiry dates
Tiny Isle Lava  Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla,    sea salt.  Keep cold.    Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies,   Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
UPC for single truffles: 11386711886   No lot codes or expiry dates
Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies,   Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies,   Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies,   Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies,   Tiny Isle  5915 Olohena Road, Unit H  Kapaa, HI 96746
Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt.  Tiny Isle  4505 Kukui St. 20A  Kapaa, HI 96746
Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz.  Tiny Isle  4505 Kukui St. 20A  Kapaa, HI 96746
UPC for Fudge Pack: 11386071195   No lot codes or expiry dates
U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
Nicotine Polacrilex Lozenge, 2 mg Mint Mini.  27 Ct Tubes, Over the Counter.  Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010.  Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons,  Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.