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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 Dec 23, 2020

EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use…

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

Boston Scientific Corporation

FDA (openFDA device enforcement)

Drugs

Reported Dec 23, 2020

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa…

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

Cipla

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 23, 2020

HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product…

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

Maquet Cardiovascular US Sales, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 23, 2020

Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative…

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

Roche Diagnostics Operations, Inc.

FDA (openFDA device enforcement)

Meat & poultry

Reported Dec 19, 2020

Nestlé Prepared Foods Recalls Lean Cuisine Baked Chicken Meal Products Due to Possible Foreign Matter Contamination

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

Nestlé Prepared Foods

USDA FSIS

Drugs

Reported Dec 16, 2020

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only,…

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

Fresenius Kabi USA, LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 16, 2020

PROKERA, non-sterile - Product Usage: Biologic corneal bandage.

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

TissueTech, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Food

Reported Dec 9, 2020

Lemonade 1/2 gallon glass bottle. UPC:7525200265. "10% Real Juice Lemonade"

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

Homestead Creamery, Inc.

FDA (openFDA food enforcement)

Drugs

Reported Dec 9, 2020

Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715),…

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

Lohxa LLC

FDA (openFDA drug enforcement)

Drugs

Reported Dec 9, 2020

REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical…

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

MPM Medical LLC

FDA (openFDA drug enforcement)

Food

Reported Dec 9, 2020

Quantum Health branded Elderberry liquid herbal extract dietary supplement is packaged in 2oz glass bottle, 12…

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

Quantum Inc.

FDA (openFDA food enforcement)

Drugs

Reported Dec 2, 2020

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx…

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

Fresenius Kabi USA, LLC

FDA (openFDA drug enforcement)

Food

Reported Dec 2, 2020

HQO High Quality Organics Organic Thyme Leaves, Whole Net Weight 30 lbs., 500 lbs. High Quality Organics 1201 Moya…

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

High Quality Organics

FDA (openFDA food enforcement)

Drugs

Reported Dec 2, 2020

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC…

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

Sunstar Americas, Inc.

FDA (openFDA drug enforcement)

Food

Reported Dec 2, 2020

Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), plastic bag, UPC 0-0082-00304-3

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

Vitamin Cottage Natural Foods Market, Inc. dba Natural Grocers

FDA (openFDA food enforcement)

Food

Reported Nov 25, 2020

Art Of Tea - Feel Better tea; Produced and Distributed by: Art of Tea LLC, Monterey Park, CA Directions: 1 Tbsp of tea…

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

Art Of Tea

FDA (openFDA food enforcement)

Medical devices

Reported Nov 25, 2020

Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with…

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

Cardinal Health 200, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Food

Reported Nov 25, 2020

Frozen French Cut Green Beans. Packaged in 20.5 lb boxes. Expiration date 11/25/2022

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

National Food Trading Corporation

FDA (openFDA food enforcement)

Food

Reported Nov 25, 2020

Rosebud's brand Elderberry Syrup Kit in a 3 oz. clear stand-up pouch (GS1 Code 852782007834).

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

Rosebud's Ranch and Garden, LLC

FDA (openFDA food enforcement)

Meat & poultry

Reported Nov 15, 2020

FSIS Issues Public Health Alert for Chicken and Pork Tamales Containing FDA-Regulated Diced Tomatoes in Puree That Have…

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

Tucson Tamale Wholesale Company LLC

USDA FSIS

Medical devices

Reported Nov 4, 2020

Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating…

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

Battelle Memorial Institute

FDA (openFDA device enforcement)

Meat & poultry

Reported Nov 4, 2020

FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter…

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

Kwik Trip, Inc.

USDA FSIS

Food

Reported Oct 28, 2020

The Spice Hunter Organic Parsley 0.23 oz. Jar UPC 8105701659 Case UPC 40081057016594

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

Sauer Brands Inc. - SLO

25 more products in this recall

FDA (openFDA food enforcement)

Medical devices

Reported Oct 21, 2020

Tina-quant Complement C4 ver.2, Catalog 05991994190

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

Roche Diagnostics Operations, 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.