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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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Seafood Company Pleads Guilty to the Illegal Sale of Oysters

12-11-2020

FDA OCI, Indian Ridge Seafood, Terrebonne Parish LA, oysters, sale, transport, illegal, unlawful, guilty plea, Lacey Act, recordkeeping, marine...

Food & drugs

2020 Medical Device Recalls

12-11-2020

List of Medical Device recalls in 2020.

Food & drugs

Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error

12-11-2020

The Cook Fixed Core Wire Guide is a curved wire guide made of stainless steel with non-reactive coating and helps insert medical devices into the...

Product safety

Zinus Recalls Bunk Beds Due Fall and Injury Hazards (Recall Alert)

12-11-2020

The welds that secure the upper bunk can come apart, causing the upper bunk to collapse, posing fall and injury hazards.

Product safety

InvoSpa Recalls Heated Blankets Due to Fire and Burn Hazards; Sold Exclusively at Amazon.com (Recall Alert)

12-11-2020

The recalled blankets can overheat, posing fire and burn hazards.  

Product safety

Quality Bicycle Products Recalls Salsa Cycles Cutthroat Bicycles Due To Injury Hazard

10-11-2020

The bicycle’s fork legs can crack or break, posing a fall hazard to the rider.

Product safety

Arena North America Recalls Swim Snorkels Due to Choking Hazard

10-11-2020

The swim snorkels can release excess material from inside the tube or mouthpiece, posing a choking hazard to the user.

Product safety

Fire Pit Tables Sold Exclusively at Big Lots Recalled Due to Fire Hazard; Manufactured by Sunjoy

10-11-2020

An incorrectly installed burner kit hose can melt and ignite, posing a fire hazard. 

Product safety

Bolek’s Craft Supplys Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of P

10-11-2020

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

Product safety

Ring Recalls Video Doorbells (2nd Generation) Due to Fire Hazard

10-11-2020

The video doorbell’s battery can overheat when the incorrect screws are used for installation, posing fire and burn hazards.

Product safety

Kohl’s Recalls Three-Wick SONOMA Goods For Life Branded Candles Due to Fire and Burn Hazards

10-11-2020

The candle’s high flames can ignite the surface of the wax or cause the glass to break, posing fire and burn hazards.  

Food & drugs

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

09-11-2020

Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date...