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Food & drugs

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

 The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...

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Food & drugs

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Bes

12-04-2018

Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain...

Product safety

L.L.Bean Recalls Knife with Sheath Due to Laceration Hazard (Recall Alert)

12-04-2018

 The knife blade can cut through the protective leather sheath, posing a laceration hazard.

Food & drugs

Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack o

11-04-2018

Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and...

Food & drugs

System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation T

10-04-2018

System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope.

Food & drugs

Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella

10-04-2018

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Food & drugs

Nine Whole Foods Market Stores Issue Voluntary Recall for Explorateur French Triple Creme Cheese Due to Possible Health Risk

10-04-2018

Whole Foods Market is voluntarily recalling Explorateur French Triple Crème cheese from nine stores located in New Mexico, Texas, Arkansas,...

Product safety

BRP Recalls All-Terrain Vehicles Due to Crash Hazard (Recall Alert)

10-04-2018

The dynamic power steering shaft can break and result in a loss of steering control, posing a crash hazard to consumers.

Food & drugs

Stewart’s Shops Issues Allergy Alert on Pint Chocolate Peanut Butter Cup Ice Cream

09-04-2018

Stewart’s Shops Corp. is recalling units of Stewart’s pint Chocolate Peanut Butter Cup ice cream because they may have been packaged incorrectly...

Food & drugs

Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution

09-04-2018

Sales restricted to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and...

Food & drugs

Club 13 Recalls Kratom Maeng Da Red Powder and Capsules Because of Possible Health Risk

09-04-2018

Club 13 of St. Augustine, FL is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of "Maeng Da Red" kratom...

Food & drugs

Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk

08-04-2018

Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of...

Food & drugs

Cut Fruit Express, Inc. Announces A Voluntary Recall of Fresh Bruschetta Mixed and Dips Because of Undeclared Soy and Milk

07-04-2018

Cut Fruit Express, Inc. of Inver Grove Heights, Minnesota is voluntarily recalling packaged Bruschetta Mixes and Dips distributed through 4/4/2018,...