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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Search Results for: recall
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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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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How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
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