FDA: Class I recall of Insulet Omnipod DASH PDM
Editor's Note The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious. The recall was initiated because of PDM battery issues, including: Battery swelling Fluid leakage from the battery…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…
FDA: Class I recall of certain Accula SARS-CoV-2 Tests
Editor's Note The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious. The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because…
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