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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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Product safety

Otis Elevator Company Recalls to Inspect Private Residence Elevators Due to Entrapment Hazard; Risk of Serious Injury or Death

17-12-2020

Children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate, and suffer...

News

Medical Device Manufacturer’s Director of Clinical Services Pleads Guilty to Causing the Adulteration of Rectal Pressure Sensor

16-12-2020

FDA OCI, Denise D’Andrea, guilty plea, medical device, adulteration, director, clinical services, Prometheus, device manufacturer, Pathway CTS...

Product safety

Cycling Sports Group Recalls Cannondale Canvas NEO Bicycles Due to Fall Hazard

16-12-2020

The front fender can detach and cause the front wheel to abruptly stop, posing a fall hazard.

Product safety

Graco Recalls Inclined Sleeper Accessory Included with Four Models of Playards to Prevent Risk of Suffocation

16-12-2020

Infant fatalities have been reported with other manufacturers’ inclined sleep products, after infants rolled from their back to their stomach or...

Product safety

Camp Chef Recalls Portable Gas Stoves Due to Fire Hazard

16-12-2020

An internal part of the gas regulator component can have a sharp edge that can wear or tear a hole in the seal causing gas to leak out of the top of...

Product safety

BRP Recalls Can-Am Screw Jacks Due to Crush Hazard

16-12-2020

The screw jack can collapse and cause the lifted vehicle to fall on a person, posing a crush hazard that can result in severe injury or death.

Product safety

LG Energy Solution Michigan Recalls Home Energy Storage Batteries Due to Fire Hazard

16-12-2020

The home batteries can overheat, posing a risk of fire and emission of harmful smoke. 

Food & drugs

Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious

15-12-2020

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex)...

News

Former Supervisor at Long Island Drug Manufacturer Pleads Guilty to Theft of Medical Products

11-12-2020

FDA OCI, Gregory Settino, guilt plea, theft, stealing, veterinary drugs, horse, Luitpold Pharmaceuticals, Shirley NY, American Regent, Adequan,...

News

Doctor Selling COVID-19 “Cure” Charged with Lying to U.S. Customs, Stealing Employee’s Identity

11-12-2020

FDA OCI, Jennings Staley M.D., COVID-19, coronavirus, hydroxychloroquine, miracle cure, treatment kit, Chinese supplier, smuggle, Skinny Beach Med...

Product safety

Homfa Cabinets Recalled Due to Tip-Over and Entrapment Hazards; Made by Shenzhen Luosi Ge Trading Co. (Recall Alert)

10-12-2020

The recalled cabinets are unstable if not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries...

Product safety

Thermo Tents Recalls Mór Series Tents Due to Fire Hazard; Tents are Mislabeled as Fire Retardant (Recall Alert)

10-12-2020

The tents are incorrectly labeled as being fire retardant (FR), posing a fire hazard.