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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New Data Tool Tracks Country of Origin to Spot Healthcare Tariff Risk
ECRI’s tool helps health systems identify products affected by tariffs and find safe, functionally equivalent alternatives to maintain supply continuity.
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