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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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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Editor's Note Logistical staff layoffs at the US Food and Drug Administration (FDA) are hindering the agency’s ability to scrutinize drug manufacturing safety in foreign countries, according to a July 7 report in ProPublica. A spokesperson from the US Department of Health and Human Services (HHS) told ProPublica that FDA…

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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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Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…

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Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…

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Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2,  Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…

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Vaccine health has been dominating the news amid ongoing measles and whooping cough outbreaks and high influenza activity last season. It is also on the minds of The Joint Commission surveyors, as the organization has updated infection control standards that took effect in July 2024 for hospitals and critical access…

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Editor's Note Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare…

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Editor's Note The Trump administration’s proposed fiscal year 2026 budget calls for slashing the Department of Health and Human Services (HHS) discretionary budget by $32 billion, a nearly 25% cut that brings the total to $95 billion. Fierce Healthcare reported the news June 2.  Although many of the proposed cuts…

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