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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

2020 Medical Device Recalls

30-04-2020

List of Medical Device recalls in 2020.

Product safety

Bellman & Symfon Recalls Flash Receivers for Reduced Hearing Persons; Unit Can Fail to Alert in an Emergency

30-04-2020

The back-up battery can fail to fully charge resulting in the receiver not working as intended and failing to flash to alert hearing-impaired persons...

Product safety

Modular Robotics Recalls Rechargeable Battery Packs Due to Burn Hazard

30-04-2020

The rechargeable battery packs can short circuit, causing them to overheat, posing a burn hazard to consumers.

Product safety

Essential Trading Post Recalls Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requiremen

30-04-2020

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

Product safety

Ximi Vogue Recalls Children’s Neck Pillows Due to Violation of the Federal Lead Paint Ban; Risk of Poisoning

30-04-2020

Paint on the zippers and zipper pulls contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and...

Food & drugs

Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sand

29-04-2020

Condies Foods of Kearns, UT is recalling 165 units of roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 05/6/2020, and...

Food & drugs

Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sand

29-04-2020

Condies Foods of Kearns, UT is recalling 165 units of roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 05/6/2020, and...

News

Court Orders Halt to Sale of Silver Product fraudulently Touted as COVID-19 Cure

29-04-2020

FDA OCI, COVID-19, coronavirus, silver, product, sale, cure, injunction, temporary, restraining order, Gordon Pedersen, Cedar Hills UT, My Doctor...

Food & drugs

CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets

29-04-2020

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following...

Food & drugs

GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due

28-04-2020

GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber...

News

Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment

27-04-2020

Dallas Wellness Center, Ozone therapy, COVID-19, treatment, cure, permanent injunction, Dallas TX, Purity Health, Jean Juanita Allen, sanitize,...

Food & drugs

UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

27-04-2020

FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat...