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US / FDA updates on medical device regulation and quality.

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168 articles in US
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FDA Issues Urgent Recall of Draeger Vapor 2000 and Vapor 3000 Anesthetic Vaporizers

The US Food and Drug Administration (FDA) has announced an urgent recall of certain Draeger Vapor 2000 and Vapor 3000…

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Olympus Expands Voluntary Recall of ViziShot 2 FLEX EBUS-TBNA Needles Due to Device Component Ejection

OLYMPUS CORPORATION has expanded its voluntary recall of the ViziShot 2 FLEX (19G) EBUS-TBNA needles due to reports of device…

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FDA Issues Urgent Recall of Medline Anesthesia Kits Due to Potential for Serious Injury or Death

On January 17, 2026, the FDA announced an urgent recall of certain Medline anesthesia kits due to the potential for…

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FDA Issues Early Alert for Boston Scientific’s Stent and Electrocautery-Enhanced Delivery System

As of January 22, 2026, the FDA has issued an early alert regarding a potentially high-risk device issue with Boston…

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FDA Issues Early Alert for Olympus Insufflation Units Due to Potential Overpressure Risks

An important medical device safety announcement was made on January 26, 2026, regarding certain Olympus insufflation units. Healthcare professionals and…

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FDA Issues Early Alert for Integra LifeSciences’ Wound and Burn Dressing Products

As of January 23, 2026, the FDA has issued an early alert regarding a potentially high-risk device issue with Integra…

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FDA Initiates Steps to Enhance Gluten Disclosure in Food Products

Meta description: FDA improves gluten ingredient disclosure in foods. Published on 2026-01-26. The US Food and Drug Administration has issued…

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FDA ImportShield Program Shows Promising Results in Enhancing Oversight at US Ports of Entry

The US Food and Drug Administration has announced the initial review of the FDA ImportShield Program (FISP), launched in August…

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Abbott Issues Important Medical Device Correction for FreeStyle Libre 3 and Libre 3 Plus Sensors in the U.S.

Abbott is addressing a critical issue affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors distributed in the…

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Live it Up Super Greens Recalled Over Potential Salmonella Contamination

Superfoods Inc., operating under the name Live it Up, has issued a voluntary recall for its Live it Up Super…

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FDA Warns of Dislodged Deaeration Chambers in Vantive Prismaflex Dialysis Tubing Sets

The FDA has issued an early alert regarding a critical issue with certain Vantive Prismaflex dialysis tubing sets. Clinical, quality,…

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Spring & Mulberry Recalls Mint Leaf Date Sweetened Chocolate Bars Over Salmonella Concerns

Spring & Mulberry Issues Recall of Mint Leaf Chocolate Bars Over Potential Salmonella Contamination On January 12, 2026, Spring &…

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