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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

Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

01-02-2018

FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease...

Product safety

Infant Bodysuits Recalled Due to Choking Hazard; Made by Alstyle

01-02-2018

The snaps at the crotch can detach, posing a choking hazard to young children.

Product safety

Cordless Electric Chainsaws Recalled Due to Injury Hazard; Distributed by Hongkong Sun Rise Trading

01-02-2018

The chain brake guard in the cordless electric chainsaw can fail and allow the chainsaw to continue operating, posing an injury hazard to users.

Product safety

Hunter Douglas Recalls Privacy Sheer Blinds Due to Strangulation Hazard (Recall Alert)

01-02-2018

The cord restraints on the combination wand/cord of the sheer blinds can break, posing a strangulation hazard to children.

Product safety

John Deere Recalls ZTrak Riding Mowers Due to Laceration Hazard (Recall Alert)

01-02-2018

The mower’s blades can continue to rotate under power when the operator leaves the seat, posing a laceration risk to the user or bystander.

News

January 31, 2018: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak

31-01-2018

January 31, 2018: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak

Food & drugs

AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error

31-01-2018

Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could...

Product safety

Vornado Air Recalls Cribside Space Heaters Due to Fire and Burn Hazards

31-01-2018

A broken motor mount can allow the electric heating element to come in contact with the interior plastic materials and ignite, posing fire and burn...