Tag: risk

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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Navigating OR construction design, compliance, approval in a booming ASC market

Editor’s Note: This page is a companion piece to the main article, Proper planning prevents OR construction, renovation cost creep. It brings together four focused updates on OR and ambulatory surgery center (ASC) construction and renovation: Regulatory shifts: The Joint Commission's updated safety and sustainability requirements for hospitals and ASCs, including new…

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By: Uyen Vo
July 23, 2025
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FDA issues safety alert for Baxter Novum IQ large volume pumps

Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus).   According to the agency’s July 22…

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By: Matt Danford
July 23, 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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FDA designates Class 1 recalls for EVH system, infusion pump

Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…

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By: Matt Danford
July 16, 2025
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FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…

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By: Matt Danford
July 10, 2025
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FDA early alerts flag pump controllers, software

Editor's Note Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter. The AIC system, which is the user control interface for the Impella catheter blood pump,…

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By: Matt Danford
July 7, 2025
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