US Nationwide - OR, FL, MA, TX, CO, OK, IL, and  MO
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery.  Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B  Lots: 42613, 2478901R, 42615, 7625701
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal.  Pin: The pin used to guide the Lock Shaft Inserter into the mating SI50002 Implant Holder can shear off under high-impact force during insertion and removal.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister    (NDC 66582-320-30), b) 90 count blister  (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister    (NDC 66582-321-30), b) 90 count blister  (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister    (NDC 66582-322-30), b) 90 count blister  (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister    (NDC 66582-323-30), b) 90 count blister  (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Cattlyst 50G is a Type A Medicated Article packaged in 50 lb (22.68 kg) multiwall paper bag with protective barrier ply.
Lot Number: HC220009;  Expiries: October 2015
Lot HC220009 was mislabeled with the manufacturing date and the expiration dates inverted.
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
5,900 units total (1,679 domestically & 4,221 internationally)
Instrument Cover Gas Spring failures.  Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position.  This may lead to the cover falling.
Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize,  Deknatel.   Indicated for use in soft tissue approximation.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Teleflex Medical, Research Triangle Park, NC,  Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico.   Indicated for use in soft tissue approximation.
Teleflex Medical, Research Triangle Park, NC, Polypropylene,  Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel.   Indicated for use in soft tissue approximation.
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical.   Indicated for use in soft tissue approximation.
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico.   Indicated for use in soft tissue approximation.
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P.   Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P.    Indicated for use in soft tissue approximation.
Worldwide Distribution -  All states in USA. OUS: List not provided at this time.
Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40.   The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
This Medical Device Correction notification affects all SynchroMed II pumps.
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk,  Medtronic is not recommending prophylactic replacement of pumps.  This communication is based on information available to date and was developed in collaboration with clinical experts. Medtronic continues to investigate this issue and we are  committed to providing updates as more information becomes available.
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
Defective container: Product distributed without inner seal on bottles.
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC  24658-0292-05
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
North Carolina; Arizona; New Jersey; California; Oklahoma
Blood products, possibly contaminated by air during collection, were distributed.
Blood and Blood Products for Reprocessing
American National Red Cross, Penn Jersey Region
Blood product, inappropriately stored in one platelet bag instead of two, was distributed.
Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir.
Siemens ADVIA Centaur Folate  Cat No. 06891541 SMN 10325366 (500 tests)  Cat No. 06367974 SMN 10310308 (100 tests)  Cat No. 00203473 SMN 10331250 (Ref) (500 tests)  Cat No. 09132781 SMN 10340209 (Ref) (2500 tests)    For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
Kit Lots ending in and exp date: 219   Exp. Date 25 March, 2014;  222   Exp Date 12 May, 2014;  224   Exp Date 04 August, 2014;  225  Exp Date 04 August, 2014;  226  Exp Date 12 September, 2014;  227  Exp. Date  06 October, 2014
Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
RetractaBed , Clinical Contour, Med - Mizer Inc.....  Model SS 762 ( 76 '' bed w/ 2 motors);  763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS.   Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
All configurations of the SS  Retractabed, Clinical Contour,  made prior to June 7 2008 may have had insufficient welding on the foot cross tube.  This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame.  If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring.
RetractaBed , Clinical Contour, Med - Mizer Inc.....  Model SS 799, 120 V, ...Max Safe Working Load 450 LBS.   Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
RetractaBed , Clinical Contour, Med - Mizer Inc.....  Model SS 801, 802, 803, 803A: 80 '' bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS.    Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
All configurations of the SS  Retractabed, Clinical Contour,  made prior to June 7, 2008 may have had insufficient welding on the foot cross tube.  This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame.  If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
American National Red Cross ARC Blood Services N.E. Region
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected in a manner that compromised the sterility of the units, were distributed.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
Alere Triage BNP Test For the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265.    The Alere Triage BNP test is a two-site immunoenzymatic (sandwich) assay. A sample is added to a  reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and  paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma  binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts  specifically with bound BNP. After incubation in a reaction vessel, materials bound to the solid phase are  held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate, Lumi-  Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a  luminometer. The light production is directly proportional to the concentration of BNP in the sample. The  amount of analyte in the sample is determined from a stored, multi-point calibration curve.  The Alere TriageR BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:  as an aid in the diagnosis of congestive heart failure (also referred to as heart failure)  as an aid in the assessment of severity of congestive heart failure  for the risk stratification of patients with acute coronary syndromes  for the risk stratification of patients with heart failure
Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS).    Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
Alere San Diego, Inc. initiated recall of Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Lots 329599 and 331265, because these lots may not recover within range when tested using certain commercially available controls.
Western Oregon and 1 consignee in Washington
the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date.   All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.
An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.
the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Sourdough Bread  24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Spelt and Millet Bread 24 oz.   The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f.   This device is intended to be used for radiography in the hospital with X-ray devices.
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ  07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Nationwide Distribution including DC and VA.
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0.  The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0).  When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur.  In addition, an unintended NO2 cell failure alarm may also occur.  The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater than 200 ppm/25 ppm respectively over a 10 second period.
The product was distributed to AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI AND WV.
Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. ''point of purchase'' display case. UPC 846107009785  (individual unit UPC 846107009788)  Product number 16593. Bissinger's Handcrafted Chocolatier, St. Louis, MO.
Milk chocolate bunny ears are packaged in dark chocolate packaging. The ingredient statement does not list milk.
Distribution US nationwide, including Michigan and a distributor in Colorado.
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
Archer Farms Brand Chocolate Hazelnut Swirl Gelato  (Italian Ice Cream), 30 FL OZ.  plastic tub, frozen. Product of Italy UPC 085239-703618
Printed on the edge lid code:   L13-102            BEST BY: 12OCT2014
Product contains undeclared peanut protein
Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally  to China,  Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and  Brazil.
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc.  in vitro diagnostic.  The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302,  Expiration: 4/2015;  Catalog number: 270-2154 (500 tests)  Reorder pack lot number: 64005207, Expiration:  6/2015; 64004750, Expiration: 11/2015
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
Product was shipped to the following states: AL, AR, GA, IL, IN, KY, MI, MS, MO, OH, SC, TN & WV.
PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: ''INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15  3948 00:48 LIA'' 0 11110 52108 8
The firm was notified of the presence of undeclared milk in the product.
Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps.   Product Usage:  The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps.  There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Product Brand Name: Alere INRatio2 PT/INR Professional Test Strips Model Number: 99008G2    Product Usage:  Usage:  Indications for use: The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the INRatio2 Monitor and INRatio2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. The Alere INRatio2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Alere San Diego is initiating a voluntary recall for the Alere INRatio2 PT/INR Professional Test Strips. This action is being initiated as a result of several complaints of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
12-Instrument Sterilization Tray;   Product Usage:  The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Giraffe Infant Warmers integrated with Nellcor SpO2.   Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Panda iRes Infant Warmers integrated with Nellcor SpO2.   Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Panda Freestanding Infant Warmers, integrated with Nellcor SpO2.   Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2.   Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device.   Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
BS9SEN BS9SES  BSAVX8  BSAVX9  BSAW3A  BSAY0P  BSAY0U  BSAY15  BSAY18  BSAY1A  BSAY1E  BSAY1F  BSAY1N  BSAY1U  BSAY1X  BSAY3C  BSAY3F  BSAY3N  BSAY3V  BSAY3X  BSAY5D  BSAY5H  BSAY8S  BSAY9C  BSAY9G  BSAY9J  BSAY9R  BSAYAR  BSAYAU  BSAYB1  BSAYBW  BSAYBX  BSAYC3  BSAYC9  BSAYCB  BSAYCC  BSAYCD  BSAYGV  BSAYGX  BSAYGY  BSAYGZ  BSAYH0  BSAYH4  BSAYH6  BSAYIG  BSAYJC  BSAYJD  BSAYOW  BSAYOZ  BSAYPM  BSAYPU  BSAYR5  BSAYSA  BSAYSJ  BSB993  BSB9AG  BSB9AJ  BSB9AR  BSB9AX  BSB9B9  BSB9BD  BSB9BE  BSB9BK  BSB9D6  BSB9D7  BSB9DB  BSB9DE  BSB9JK  BSB9JU  BSB9KG  BSB9KU  BSB9KY  BSB9NW  BSB9NX  BSB9NY  BSB9NZ  BSB9P3  BSB9P6  BSB9PA  BSB9PE  BSB9PG  BSB9PK  BSB9PL  BSB9PR  BSB9PY  BSB9R0  BSB9R3  BSB9R5  BSB9R7  BSB9R9  BSB9RC  BSB9RL  BSB9RY  BSB9RZ  BSB9S2  BSB9S3  BSB9S5  BSB9SJ  BSB9SY  BSB9SZ  BSB9T4  BSB9T8  BSB9TA  BSB9TD  BSB9TG  BSB9TJ  BSB9TM  BSB9TS  bsb9tu  BSB9TX  BSB9TZ  BSB9U1  BSB9X6  BSB9X7  BSB9X8  BSB9X9  BSB9XA  BSB9XF  BSB9XG  BSB9XR  BSB9XX  BSB9Y6  BSB9Y7  BSB9YB  BSBCUJ  BSBCUS  BSBCV1  BSBCV2  BSBCVB  BSBCWP  BSBOTA  BSBOTE  BSBOU2  BSBOU8  BSBPTL  BSBXTL  BSBXTT  BSBXTX  BSBXU1  BSBXUO  BSCE5J  BSCEC4  BSCEC5  BSCEC6  BSCEE5  BSCEEC  BSCEED  BSCEEF  BSCEEH  BSCEEJ  BSCEEW  BSCEHH  BSCEHN  BSCEHR  BSCEHW  BSCEHX  BSCEHZ  BSCEKP  BSCEKT  BSCEKV  BSCM9V  BSCMA8  BSCMA9  BSCMAD  BSCZPT  BSCZPU  BSCZPW  BSCZPY  BSCZR6  BSCZR7  BSCZR9  BSCZRC  BSCZRO  BSCZRP  BSCZRW  BSD0B1  BSDOAK  BSDOAT  BSDOAU  BSDOAY  BSDOAZ  BSEJGJ  BSA41K  BSAY0K  BSAY21  BSAYA0  BSAYBC  BSAYBH  BSAYBN  BSB9PX  BSB9RR  BSB9SB  BSB9TH  BSB9SA  BSB9AV  BSBCV5  BSCZRJ  BSCZRY
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
TX1 Tissue Removal System.  TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Distributed to all Wegmans stores in 6 states: MA, MD, NJ, NY, PA, VA
Scale label printed with ''EASTER BREAD NET WT 17oz (1.06lb)'' UPC 0 77890 32431 8, packaged in clear plastic bag
Wegmans Food Markets, Inc. has initiated a voluntary recall of all Wegmans Easter Bread (braided loaf) 17 oz., UPC 0 77890 32431 8 (all code dates) because it contains egg, which are not declared on the label.
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001.  A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Bausch & Lomb Inc- Greenville Solutions Plant
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.
Out of specification results for one of the two disinfectants.
Medline Skintegrity Moisturizing Lotion, made with oatmeal, aloe & vitamin e, 2 & 4 oz btls, Manufactured in USA for Medline Industries, Inc., Mundelein, IL 60060 UPC 0 80196 75401 7
1,401 cs/36/2 oz bottles & 78 cs/36/4 oz bottles
Kutol Products Company is voluntarily recalling the affected products as they were found to be out of specification for Aerobic Plate Count and presence of gram negative bacteria.  Specification for Aerobic Plate Count is < 100 cfu per gram with results for both affected product lots being Too Numerous To Count (TNTC).  Specification for gram negative bacteria is ''negative'' with results for both affected product lots being ''positive'' for gram negative bacteria.  The gram negative bacteria was identified as pseudomonas aeruginosa.
FL, GA, IN, MD, MI, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA and Puerto Rico
Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala
Unapproved fungicide residue detected on random sample.  Carbendizam at 28 ppb
US Nationwide Distribution - AL, AZ, AR, CA, CO, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI.
Mar Cor Purification, Central Water Platform (CWP),  102, 104 and 106.   Product Usage:   The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106.  This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve.  The potential exists that the water inlet solenoid valve could cease to function.  If this occurs, CWP will stop producing reverse osmosis water.
Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.
Mangiacotti  - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.
Microbial Contamination of Non-Sterile Products:  Elevated counts of bacteria was found, Serratia liquefaciens.
Mangiacotti  - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .
Mangiacotti  - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti,  Attleboro, MA 02703.
Mangiacotti  - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Mangiacotti  - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Mangiacotti  - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.