Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection
Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.
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Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk
The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.
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New Artificial Heart Technology Earns FDA Breakthrough Device Designation
The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.
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FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
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Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise
While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
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