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Sterility and contamination recalls

Sterility recalls cover injectable medication, surgical and wound-care supplies and the equipment used with them. A breach of sterility does not mean anyone was harmed; it means the product can no longer be assumed safe for its use, so the notice usually asks clinicians and distributors to quarantine remaining stock.

3,034 stored notices, reported between Jun 20, 2012 and Sep 23, 2026. Newest first.

Drugs

Reported May 8, 2013

"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2013

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Warner Chilcott Company LLC

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2013

TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Axium Healthcare Pharmacy dba Balanced Solutions Compounding

25 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2013

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Sandoz Incorporated

FDA (openFDA drug enforcement)

Medical devices

Reported Apr 24, 2013

REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet U.K., Ltd.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 24, 2013

Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edwards Lifesciences, LLC

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 24, 2013

IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Intuitive Surgical, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Food

Reported Apr 24, 2013

Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

La Preferida Inc.

FDA (openFDA food enforcement)

Drugs

Reported Apr 24, 2013

Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b)…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Pfizer Inc.

10 more products in this recall

FDA (openFDA drug enforcement)

Food

Reported Apr 24, 2013

Ideal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g).…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zumbro River Brand, Inc.

1 more product in this recall

FDA (openFDA food enforcement)

Medical devices

Reported Apr 17, 2013

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Lighthouse For The Blind

7 more products in this recall

FDA (openFDA device enforcement)

Food

Reported Apr 17, 2013

ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ShanTea LLC

1 more product in this recall

FDA (openFDA food enforcement)

Drugs

Reported Apr 10, 2013

Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Dr Reddys Laboratories Tennessee LLC

FDA (openFDA drug enforcement)

Drugs

Reported Apr 10, 2013

0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hospira Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Apr 10, 2013

LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

LeMaitre Vascular, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 10, 2013

Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 3, 2013

Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cardinal Health

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 3, 2013

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

CareFusion 213, LLC

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 3, 2013

Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Microbiologics Inc.

FDA (openFDA device enforcement)

Drugs

Reported Apr 3, 2013

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Pfizer Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 27, 2013

Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

DePuy Orthopaedics, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 27, 2013

Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 -…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Extremity Medical LLC

FDA (openFDA device enforcement)

Drugs

Reported Mar 27, 2013

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hospira Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 27, 2013

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stryker Howmedica Osteonics Corp.

FDA (openFDA device enforcement)

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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.