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.
Category: Recalls
Recalls
Latest
Recalls
Latest
Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Recalls
Latest
Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
Recalls
Latest
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.
Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.
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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk
The devices may have cracks that could lead to patient rebreathing of exhaled gases.
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FDA Issues Class I Recall for Ambu Manual Resuscitators
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.
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FDA Announces Class I Recall for ICU Medical Infusion Pump
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.
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Recalls
Latest
Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
