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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.

3,091 stored notices, reported between Jun 20, 2012 and Nov 18, 2026. Newest first.

Medical devices

Reported Dec 21, 2016

Cellfina Prep Pack, Part No. CP1

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

Ulthera Inc.

FDA (openFDA device enforcement)

Food

Reported Dec 14, 2016

4C All Natural Parmesan Grated Cheese, UPC 41387-33126, 6 oz

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

4 C Foods, Corp.

7 more products in this recall

FDA (openFDA food enforcement)

Food

Reported Dec 14, 2016

Manila Sky Purple Yumm Ice Cream 16 oz.

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

AC Creamery

FDA (openFDA food enforcement)

Food

Reported Dec 14, 2016

Agave Dream Lavender 1 Pint UPC Code 8 9934900206 2

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

Agave Dream

4 more products in this recall

FDA (openFDA food enforcement)

Food

Reported Dec 14, 2016

Cheese Stick w/Beef Stick Meal Break, Item #61406

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

E S Foods

19 more products in this recall

FDA (openFDA food enforcement)

Drugs

Reported Dec 14, 2016

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness…

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

Fallon Wellness Pharmacy, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 14, 2016

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with…

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

Halyard Health, Inc.

FDA (openFDA device enforcement)

Food

Reported Dec 14, 2016

Nancy's Fancy Butterscotch Budino Gelato 16 oz. UPC Code 51005 00329

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

ISB Food Group, LLC

3 more products in this recall

FDA (openFDA food enforcement)

Food

Reported Dec 14, 2016

Weight Watchers Smart Ones, Chocolate Chip Cookie Dough Sundae, Keep Frozen, 4 Individual Sundaes, 4-2.11 OZ (60g), NET…

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

Kraft Heinz Foods Company

FDA (openFDA food enforcement)

Food

Reported Dec 14, 2016

McConnell's Fine Ice Cream Dutchman's Chocolate

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

McConnell's Ice Cream, Inc.

6 more products in this recall

FDA (openFDA food enforcement)

Drugs

Reported Dec 14, 2016

Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

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

North American Rescue LLC.

8 more products in this recall

FDA (openFDA drug enforcement)

Food

Reported Dec 14, 2016

Taylor Farms Veggie & Hummus Bistro Box: Baby Carrots, Hummus Dip, Grape Tomatoes, Flatbread squares, Celery Sticks.…

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

Taylor Farms Pacific Inc. (MacArthur Facility)

FDA (openFDA food enforcement)

Meat & poultry

Reported Dec 9, 2016

FSIS Issues Public Health Alert For Possibly Undercooked Ready-To-Eat Chicken Products That Have Been Incorporated Into…

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

National Steak Processors (2024), LLC.

USDA FSIS

Medical devices

Reported Dec 7, 2016

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

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

B. Braun Medical, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Dec 7, 2016

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

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

Cadila Pharmaceuticals Limited

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 7, 2016

Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04…

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

Greatbatch Medical

FDA (openFDA device enforcement)

Food

Reported Dec 7, 2016

ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)

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

Island Soups Company Inc.

5 more products in this recall

FDA (openFDA food enforcement)

Drugs

Reported Dec 7, 2016

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in…

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

Par Pharmaceutical, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

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

Synthes (USA) Products LLC

FDA (openFDA device enforcement)

Medical devices

Reported Dec 7, 2016

ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow…

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

Teleflex Medical

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 30, 2016

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed…

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

Depuy Orthopaedics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 30, 2016

Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002…

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

Greatbatch Medical

FDA (openFDA device enforcement)

Medical devices

Reported Nov 30, 2016

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution)…

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

Hologic, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Nov 30, 2016

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL…

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

Hospira Inc.

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.