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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

RESURRECTIONbeauty Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Pois

21-11-2019

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

Product safety

SCARPA North America Recalls Ski Boots Due to Fall Hazard

21-11-2019

The ski boot shell can crack, posing a fall hazard and risk of injury to the consumer.  

Food & drugs

Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potent

20-11-2019

Mondelēz Global LLC announced today a voluntary recall of a limited quantity of Cheese Nips (11 oz. Box) product in the United States due to the...

Food & drugs

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence o

20-11-2019

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution,...

Product safety

Grace Digital Recalls EcoBoulder Speakers That Can Overcharge and Burst; Impact Hazard

20-11-2019

The speaker’s battery can become overcharged and burst, posing an impact hazard.

Product safety

B&B Acquisition Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of P

20-11-2019

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

Product safety

Deck Source Recalls Cutek Proclean Due to Violation of FHSA Labeling Requirements; Risk of Poisoning

20-11-2019

The product contains the hazardous substance oxalic acid. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting...

Food & drugs

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence o

19-11-2019

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution,...

Food & drugs

Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers

19-11-2019

The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery...

Food & drugs

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Provider

19-11-2019

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope...

Product safety

United National Closeout Stores Recalls Isometric Exercise Devices Due to Projectile Hazard; Devices Sold at Burlington Stores

19-11-2019

The handle grips on each end can break during use and cause parts to be forcefully ejected from the shaft, posing a risk of injury from impact to the...

Product safety

Flying Tiger Copenhagen Recalls Crocodile Candleholders Due to Fire Hazard

19-11-2019

The candleholders are flammable and can catch on fire, posing a fire hazard when the candle burns down.