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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

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assuran

07-09-2017

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that...

Product safety

Studio Fun International Recalls Slap Bracelets Sold with Children’s Storybooks Due to Laceration Hazard

07-09-2017

The metal band can wear through the fabric covering of the slap bracelet, posing a laceration hazard.

Product safety

Smith Recalls Ski and Snowboard Helmets Due to Risk of Head Injury

07-09-2017

The buckle on the helmet can disengage, posing a risk of head injury.

Product safety

L.L. Bean Recalls Toddler Sweater Fleece Pullovers Due to Choking Hazard (Recall Alert)

07-09-2017

The snaps on the fleece pullovers can detach, posing a choking hazard.

Food & drugs

Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

06-09-2017

If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health...

Food & drugs

Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

06-09-2017

Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.

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Dominican Republic Travel Warning

06-09-2017

Traveling

Haiti Travel Warning

06-09-2017

Product safety

Ameriwood Home Recalls Chests of Drawers Due to Serious Tip-Over and Entrapment Hazards

06-09-2017

The recalled chests of drawers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in...

Product safety

Kawasaki Recalls Brute Force 300 All-Terrain Vehicles Due to Fire Hazard

06-09-2017

The fuel tap or carburetor can leak fuel, posing a fire hazard.

Product safety

Ameriwood Home Recalls Chests of Drawers Due to Tip-Over and Entrapment Hazards

06-09-2017

The recalled chests of drawers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in...

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September 5, 2017: New Hampshire Residents Plead Guilty to Conspiracy Involving Misbranded Drugs

05-09-2017

September 5, 2017: New Hampshire Residents Plead Guilty to Conspiracy Involving Misbranded Drugs