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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.

Medical devices

Reported Oct 28, 2015

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For…

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

Smith & Nephew, Inc., Endoscopy Div.

3 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Oct 21, 2015

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC…

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

Apotex Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Oct 21, 2015

Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603)…

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

Bedford Pharmacy

12 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Oct 21, 2015

Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box,…

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

Midway Importing, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Oct 21, 2015

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials,…

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

Nephron Pharmaceuticals Corp.

FDA (openFDA drug enforcement)

Drugs

Reported Oct 21, 2015

Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07,…

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

Tribute Pharmaceuticals US Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Oct 14, 2015

Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba…

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

Diabetes Corporation

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 14, 2015

Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park,…

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

Ortho Solutions Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 14, 2015

regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The…

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

Resource Optimization & Innovation LLC

76 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2015

Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

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

Arrow International Inc.

FDA (openFDA device enforcement)

Drugs

Reported Oct 7, 2015

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Hartley Medical Center Pharmacy, Incorporated

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Oct 7, 2015

All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An…

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

Medistat RX LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 7, 2015

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp,…

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

US Endoscopy Group Inc.

FDA (openFDA device enforcement)

Meat & poultry

Reported Oct 2, 2015

Aspen Foods Recalls Frozen, Raw, Stuffed & Breaded Chicken Products Due to Possible Salmonella Enteritidis Contamination

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Aspen Foods

USDA FSIS

Drugs

Reported Sep 30, 2015

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter…

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

Baxter Healthcare Corporation

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 30, 2015

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301,…

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

Ecolab Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 30, 2015

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

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

Resource Optimization & Innovation LLC

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 23, 2015

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only,…

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

EMD Serono, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 23, 2015

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01,…

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

Intuitive Surgical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 23, 2015

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient…

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

Med Tec Inc.

FDA (openFDA device enforcement)

Drugs

Reported Sep 23, 2015

5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America,…

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

The Compounding Pharmacy

381 more products in this recall

FDA (openFDA drug enforcement)

Meat & poultry

Reported Sep 17, 2015

FSIS Issues Public Health Alert For Stuffed Chicken Products Due To Possible Salmonella Contamination

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

Fsis

USDA FSIS

Drugs

Reported Sep 16, 2015

DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient…

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

3M Company - Health Care Business

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 16, 2015

Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous…

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

Elcam Medical, Inc.

1 more product in this recall

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.