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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

Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cyberse

29-08-2017

Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery...

News

August 28, 2017: Shrewsbury Man Pleads Guilty to Operating Counterfeit Steroid Scheme

29-08-2017

August 28, 2017: Shrewsbury Man Pleads Guilty to Operating Counterfeit Steroid Scheme

Product safety

Fabri-Tech Recalls Infant Rompers Due to Choking Hazard; Sold Exclusively at Cracker Barrel Old Country Stores

29-08-2017

The buttons on the shoulder straps can detach, posing a choking hazard to children.

Food & drugs

Dedinas-Franzak Enterprises Issues Allergy Alert On Undeclared Milk In Big Win Butter Popcorn

28-08-2017

Dedinas-Franzak Enterprises is recalling Big Win, Butter Popcorn Artificially Flavored 5 OZ, UPC #0-11822-58492-0, This product is artificially...

Food & drugs

Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increas

28-08-2017

Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm...

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Ethiopia Travel Warning

26-08-2017

Food & drugs

Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device

25-08-2017

Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.

Food & drugs

Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

25-08-2017

Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed...

Traveling

Ethiopia Travel Warning

25-08-2017

Traveling

Bangladesh Travel Warning

24-08-2017

Product safety

Dr. Martens Vegan Boots Recalled by Airwair Due to Chemical Exposure Hazard

24-08-2017

Prolonged and direct contact with the boot tongue lining can expose the wearer to the chemical benzidine.  

Product safety

Arc’teryx Recalls Ski Mountaineering Boots Due to Fall Hazard

24-08-2017

The axis pin located at the rear of the boot can dislodge, resulting in damage to the boot and posing a fall hazard.