FDA tells hospitals to inspect certain infant breathing circuits
The FDA says hospitals should inspect Draeger VentStar Resus Neo circuits for cracked or detached hoses before use and discard damaged units.
Medical Devices
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FDA Classifies Luna G3 Recall After Firmware Could Stop Therapy
FDA classified a nationwide Luna G3 APAP recall after firmware may trigger shutdowns under specific conditions. Patients should check their device.
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Boston Scientific Cyber Incident Disrupts Device Shipments
Boston Scientific says a cybersecurity incident is disrupting manufacturing and shipments while delaying remote-monitoring activation for some new cardiac devices.
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Justice Department seeks penalties and relief in Edwards LifeSciences acquisition case
The Justice Department filed an antitrust complaint over Edwards LifeSciences’ acquisition of JC Medical from Genesis MedTech, alleging the transaction was structured to avoid required federal reporting.
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FDA opens early alert for Boston Scientific percutaneous catheter issue
The FDA listed an early alert on July 24, 2026, involving a Boston Scientific percutaneous catheter and said it was collecting additional information.
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FDA Classifies Abiomed Impella Kit Recall as Class I
The FDA classified a recall of select Abiomed introducer kits as Class I after thrombus reports. Hospitals should stop use, quarantine units and arrange returns.
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United States: FDA warns on 7 million Omnipod pods in voluntary correction
FDA says specific Omnipod lots may underdeliver insulin. Users should check lot numbers, stop using affected pods, and request free replacements.