Tag: recall

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React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

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Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking

The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.

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ECRI Announces Winners of 2025 Alerts Impact Award

The annual award recognizes excellence in recall management among healthcare institutions worldwide.

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React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk

Aug 29, 2025

The devices may have cracks that could lead to patient rebreathing of exhaled gases.

FDA Issues Class I Recall for Ambu Manual Resuscitators

Aug 29, 2025

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

FDA Announces Class I Recall for ICU Medical Infusion Pump

Aug 29, 2025

A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.

Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect

Aug 29, 2025

The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Aug 6, 2025

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Aug 5, 2025

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

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Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.