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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 Mar 26, 2014

Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx…

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

Biomet 3i, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 19, 2014

Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave…

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

Biomet 3i, LLC

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 19, 2014

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

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

Boston Scientific Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Mar 19, 2014

Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable…

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

Gyrus Medical, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 19, 2014

Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be…

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

Lin-Zhi International Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Mar 19, 2014

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S…

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

Specialty Medicine Compounding Pharmacy, P.C.

FDA (openFDA drug enforcement)

Drugs

Reported Mar 12, 2014

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen…

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

Dr. Reddy's Laboratories, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 12, 2014

Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600,…

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

Greatbatch Medical

FDA (openFDA device enforcement)

Drugs

Reported Mar 12, 2014

Lidocaine 4% Urethral Gel

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

Natures Pharmacy & Compounding Center

47 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 5, 2014

Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only…

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

Orthofix, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 5, 2014

Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm…

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

Remel Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 5, 2014

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The…

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

Terumo Cardiovascular Systems Corporation

FDA (openFDA device enforcement)

Food

Reported Mar 5, 2014

The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients.…

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

The Cultured Kitchen

5 more products in this recall

FDA (openFDA food enforcement)

Food

Reported Mar 5, 2014

Cactus Leaves (Nopales), 44 lbs.

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

Tijuana'S Produce Co.

FDA (openFDA food enforcement)

Food

Reported Feb 26, 2014

BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper…

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

El Encanto, Incorporated

38 more products in this recall

FDA (openFDA food enforcement)

Medical devices

Reported Feb 19, 2014

Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp.…

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

Stryker Howmedica Osteonics Corp.

1 more product in this recall

FDA (openFDA device enforcement)

Meat & poultry

Reported Feb 15, 2014

Washington Firm Recalls Dried Egg Products Due to Possible Salmonella Contamination

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

Washington Firm

USDA FSIS

Drugs

Reported Feb 12, 2014

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

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

Apothecure, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Feb 12, 2014

Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55)…

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

Faria Limited LLC dba Sheffield Pharmaceuticals

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Feb 12, 2014

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

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

Fusion Pharmaceuticals, LLC

FDA (openFDA drug enforcement)

Drugs

Reported Feb 5, 2014

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL…

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

Hospira Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Feb 5, 2014

Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts,…

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

Humco Holding Group, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Feb 5, 2014

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

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

NuVision Pharmacy, Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Feb 5, 2014

ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742…

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

The Mentholatum Co.

4 more products in this recall

FDA (openFDA drug 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.