Tag: FDA recall

FDA issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific

Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…

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By: Tarsilla Moura
August 28, 2025
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FDA announces Class 1 recall for Draeger breathing filters

Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…

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By: Matt Danford
August 13, 2025
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FDA issues Class I recall for Philips BiPAP ventilators

Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…

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By: Matt Danford
August 5, 2025
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FDA designates Class I recall for disposable surgical stapler cartridge correction

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement,  the recall…

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By: Matt Danford
July 28, 2025
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FDA designates Class I recall for arterial cannulae due to exposed wire risk

Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…

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By: Matt Danford
July 25, 2025
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FDA designates Class I recall for mobile lift component

Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…

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By: Matt Danford
July 24, 2025
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FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators

Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…

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By: Matt Danford
July 22, 2025
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FDA designates Class I recall for manual resuscitator

Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…

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By: Matt Danford
July 21, 2025
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FDA issues early alert for microbore extension sets

Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…

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By: Matt Danford
July 18, 2025
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FDA designates Class 1 recall for cranial drill

Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…

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By: Matt Danford
July 17, 2025
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