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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

Pretty Thai Issues Allergy Alert on Undeclared Peanuts in Mislabeled Peanut Sauce

10-09-2020

Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sauce that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk...

Product safety

Organic Aromas Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoni

10-09-2020

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act...

Product safety

Residential Elevators Recalls Elevators Due to Impact Hazard (Recall Alert)

10-09-2020

The elevator cab can rise unexpectedly to the top of the elevator shaft and abruptly stop, posing an impact hazard to any occupants in the elevator...

Food & drugs

2020 Safety Communications

09-09-2020

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

Food & drugs

FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therap

09-09-2020

The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if...

Food & drugs

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Sub

09-09-2020

Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found...

Product safety

Cycling Sports Group Recalls Front Racks for Cannondale Treadwell Bicycles Due to Fall Hazard

09-09-2020

The recalled front racks on the bicycles can detach and cause the bicycle’s front wheel to abruptly stop, posing a fall hazard.

Product safety

Royal Gourmet Recalls Deluxe Gas Grills Due to Fire Hazard; Sold Exclusively at Wayfair.com

09-09-2020

The grill’s plastic regulator hose can melt and catch fire, posing a fire hazard.

Product safety

WHILL Recalls WHILL Personal Electric Vehicles Due to Crash and Injury Hazards

09-09-2020

The vehicle’s control pad can malfunction causing the power to turn on/off and the speed to increase/decrease, posing crash and injury hazards.

News

Opioid Manufacturer Indivior’s Former Global Medical Director Pleads Guilty in Connection with Drug Safety Claims

08-09-2020

FDA OCI, opioid, Indivior, director, guilty plea, drug safety claims, Timothy BAXTER, Suboxone Film, misdemeanor, misbranded drug, top medical...

News

Supervisor at Long Island Drug Manufacturer Indicted for Theft of Over a Million Dollars Worth of Medical Products

08-09-2020

FDA OCI, supervisor, Long Island, drug, indictment, theft, Gregory Settino, equine illness, false statements, federal agents, Luitpold...

Food & drugs

DMM VISSION, S.A. DE C.V. Issues Voluntary Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles Due to the Po

08-09-2020

Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear...