Editor's Note The Food and Drug Administration (FDA) on December 9 identified the recall by Remel, Inc, of its Thermo Scientific Gram Negative IVD AST Sensititre Plate as Class I, the most serious. The Plates are used to test the susceptibility of Gram-negative bacterial infections to specific antibiotics. The recall…

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Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…

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Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…

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Editor's Note The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA. No…

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Editor's Note The Food and Drug Administration (FDA) on October 19 identified the recall by Philips Respironics of certain masks for BiPAP and CPAP machines as Class I, the most serious. The recall was initiated because magnetic headgear clips that hold the masks in place can cause injury or death…

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Editor's Note The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious. The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a…

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Editor's Note The Food and Drug Administration (FDA) on September 23 identified the recall by Philips Respironics of certain models of its BiPAP machines as Class I, the most serious. The recall was initiated because certain machines may contain a plastic contaminated with a noncompatible material. If the plastic is…

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Editor's Note The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious. The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances…

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Editor's Note The Food and Drug Administration on September 12 identified the recall by Medtronic Xomed of its NIM Contact Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube as Class I, the most serious. The recall was initiated after Medtronic Xomed received customer complaints about obstruction of…

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Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…

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