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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

UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers

27-04-2020

The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients...

Food & drugs

The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons

27-04-2020

The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to...

Food & drugs

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

27-04-2020

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine,...

Food & drugs

Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers

27-04-2020

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits,...

Food & drugs

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

27-04-2020

An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape...

Food & drugs

Medical Glove Conservation Strategies: Letter to Health Care Providers

27-04-2020

FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care...

Food & drugs

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

27-04-2020

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

Food & drugs

Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Se

24-04-2020

FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease...

Food & drugs

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

23-04-2020

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine,...

Product safety

Leviton Manufacturing Recalls Electrical Connection Devices Due to Shock Hazard

23-04-2020

The electrical connection devices can have mislabeled terminal markings, posing an electrical shock hazard.

Product safety

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

23-04-2020

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

Product safety

Natural Health Partners Recalls Dr. Mercola Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Require

23-04-2020

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