Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…

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Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…

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Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…

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Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…

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Editor's Note The Food and Drug Administration (FDA), on July 11, identified the recall by Megadyne of its Mega 2000 and Mega Soft reusable patient return electrodes as Class I, the most serious. The recall was initiated after Megadyne received reports of pediatric and adult patients receiving burn injuries during…

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Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…

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Editor's Note The Food and Drug Administration, on June 12, identified the recall of the rechargeable Walnut Wearable Smart Thermometer as Class I, the most serious. BearCare, Inc, is recalling the thermometers after receiving reports of skin burns and irritation resulting from use of the device. The company reports five…

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Editor's Note The Food and Drug Administration (FDA), on June 5, identified the recall by Abiomed of specific Impella 5.5 with SmartAssist heart pumps as Class I, the most serious. The recall was initiated because of fluid leaking from the purge sidearm of the pump. If the leak issue is…

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Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…

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Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…

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