Editor's Note The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death. The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the…

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Editor's Note Endovascular devices used to block aneurysm blood flow are the subject of the latest recall to be designated Class 1—the most severe designation indicating serious risk of injury or death—by the US Food and Drug Administration (FDA). As detailed in the agency’s March 18 announcement, Medtronic Neurovascular is…

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Editor's Note Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold, according to a March 5 early alert from the US Food and Drug Administration (FDA). The FDA notice concerns the Sigma Spectrum Infusion System…

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Editor's Note The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death. The Getinge recall is an expansion of a 2024…

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Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…

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Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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Editor's Note The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These…

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Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…

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Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…

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