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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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Traveling

Kenya Travel Alert

27-09-2017

Traveling

Kenya Travel Alert

27-09-2017

Product safety

DICK’S Sporting Goods Recalls Resistance Tubes Due to Injury Hazard

27-09-2017

The resistance tubes can break while in use and strike the user, posing an injury hazard.

Food & drugs

For Immediate Release: Silver Spring Foods, Inc. Voluntarily Recalling Waterfront Bistro Tartar Sauce Due To Possible Mislabeli

26-09-2017

Silver Spring is voluntarily recalling Waterfront Bistro Tartar Sauce because there is a chance an incorrect back label was attached to the product,...

Food & drugs

Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing B

26-09-2017

If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying...

Product safety

Saber Grills Recalls Grills and LP Regulators Due to Fire and Burn Hazards

26-09-2017

The grills’ LP regulator can allow gas to flow at a higher pressure than intended, which can result in a gas leak and flame burst from the burner...

Food & drugs

TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortali

25-09-2017

UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse...

News

September 22, 2017:Woman Admits to Illegally Selling Prescription Drugs Not Approved for Use in the US

25-09-2017

September 22, 2017:Woman Admits to Illegally Selling Prescription Drugs Not Approved for Use in the US

Traveling

Eritrea Travel Warning

25-09-2017

Traveling

Eritrea Travel Warning

25-09-2017

Product safety

Pro-Tec Recalls Multisport Helmets Due to Risk of Head Injury

25-09-2017

The buckle on the helmet fails to meet current federal safety standards, posing a risk of head injury.

Product safety

Delta Recalls Strollers Due to Fall Hazard

25-09-2017

The stroller leg bracket can break, posing a fall hazard to infants in the stroller.