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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

Biohealth Nutrition Announces the Recall of Precision Blend Cookies and Cream Product for Undeclared Allergen

11-07-2017

Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because product labels failed to declare the food allergen, wheat....

Product safety

Superpedestrian Recalls Electric Bicycle Conversion Wheels Due to Fall and Crash Hazards (Recall Alert)

11-07-2017

The rear axle can fail, posing fall and crash hazards to riders.

Food & drugs

Coborn's, Inc. Issues Recall of Incorrectly Labeled Gluten Free Chocolate Chip Bars Due To Undeclared Milk

10-07-2017

Coborn's, Inc. of St. Cloud, Minn. is recalling packages of its Gluten Free Chocolate Chip Bars, some of which were incorrectly labeled as Gluten...

Food & drugs

Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables

06-07-2017

During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices...

Food & drugs

Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals

06-07-2017

Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to...

Food & drugs

Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks

06-07-2017

Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if...

Food & drugs

Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleed

06-07-2017

UPDATED 07/06/2017. Voluntary recall closed on June 23, 2017. FDA continues to recommend that health care providers discuss with their patients all...

Food & drugs

Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids

06-07-2017

Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including...

Food & drugs

Atar Extension Cables by Oscor: Recall - Cable Separating from Connector

06-07-2017

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Posted 07/06/2017

Food & drugs

Voluntary Recall of CLIF BUILDER'S Bar Chocolate Mint Flavor, CLIF Kid Zbar Protein Chocolate Mint and CLIF Kid Zbar Protein Ch

06-07-2017

Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER'S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and...

Product safety

Cub Cadet Recalls Utility Vehicles Due to Crash Hazard (Recall Alert)

06-07-2017

Air in the brake system can cause brake failure, posing a crash hazard to the user or bystander.

Food & drugs

Hardcore Formulations Issues Voluntary Nationwide Recall of Ultra-Sten and D-Zine Capsules Due to Labeling that it Contains Ana

05-07-2017

Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products...