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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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Product safety

Children’s Tool Kits Recalled by Grizzly Industrial Due to Violation of Federal Lead Content Ban and Toy Safety Requirements

19-03-2020

The tool belt, hammer and suspenders (model H3044) contain excessive levels of lead, violating the federal lead content standard.  In addition,...

Product safety

Kawasaki USA Recalls Off-Highway Utility Vehicles Due to Fuel Leak, Fire Hazards (Recall Alert)

19-03-2020

Debris can ignite on the vehicle’s exhaust manifold; and frozen water can block the breather hose allowing oil to leak, posing a fire...

Product safety

Lilly of New York Children’s Winter Boots Recalled by Kidz Concepts Due to Violation of Federal Lead Content Ban; Sold Exclusiv

19-03-2020

The boots’ sole contain levels of lead that exceed the federal lead content ban.  Lead is toxic if ingested by young children and can cause...

Product safety

Kids & Koalas Baby Walkers Recalled Due to Fall and Entrapment Hazards; Sold Exclusively on Amazon.com (Recall Alert)

19-03-2020

The baby walkers fail to meet the federal safety standard.  Specifically, they can fit through a standard doorway and are not designed to stop...

Product safety

C3 Manufacturing Recalls Perfect Descent Climbing Systems Climbing Belay Devices Due to Fall Hazard

19-03-2020

The belay climbing device can loosen and can cause slack on the rope, allowing the climber to fall.  Climbing while tethered to a malfunctioning...

Product safety

Kawasaki USA Recalls Off-Highway Utility Vehicles Due to Oil Leak, Fire Hazard (Recall Alert)

19-03-2020

Debris can ignite on the vehicle’s exhaust manifold; and frozen water can block the breather hose allowing oil to leak, posing a fire...

Food & drugs

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion

18-03-2020

CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion

Food & drugs

2020 Medical Device Recalls

18-03-2020

List of Medical Device recalls in 2020.

Product safety

Belle Chemical Recalls Sodium Hydroxide and Potassium Hydroxide Products Due to Failure to Meet Child-Resistant Packaging Requi

18-03-2020

The products contain sodium hydroxide or potassium hydroxide which must be in child resistant packaging as required by the Poison Prevention...

Product safety

Earth Sonnets Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

18-03-2020

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act...

Product safety

Earthroma Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (R

18-03-2020

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act...

Product safety

Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packagi

18-03-2020

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the...