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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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Fresenius Kabi Issues Limited Ivenix LVP Recall

Fresenius Kabi recalled a specific lot of Ivenix LVP Primary Administration Sets due to a defect that could cause uncontrolled flow.

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Fresenius Kabi Recalls Ivenix Infusion Systems LVP Software

Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients, necessitating an urgent update to version 5.9.1.

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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.

Olympus Warns About Risk with Improper Bronchoscope Use

Nov 10, 2023

Olympus warned customers of issues involving use of certain bronchoscopes with high-frequency therapy equipment.

Medical Device Recalls Fell 4.4% in Q2 2023

Aug 21, 2023

Medical device recalls fell 4.4% in Q2 2023 to 241 events, with quality concerns accounting for the majority of recalls.

Cardiosave Hybrid and Rescue IABPs Recalled for Electrical Issues

Aug 11, 2023

Getinge recalled the Cardiosave Hybrid and Rescue IABPs because they may shut down unexpectedly due to electrical failure.

Draeger Issues Recall for Carina Ventilators

Aug 1, 2023

Draeger initiated a voluntary recall notification for Draeger Carina Sub-Acute Care Ventilators to address a possible contamination issue.

Baxter Finds Urgent Software Issue With Spectrum Infusion Pumps

Jul 31, 2023

Baxter announced an urgent issue with its Spectrum V8 and Spectrum IQ infusion pumps related to recent software updates.

Abiomed Recalls Impella Left-Sided Blood Pumps

Jul 28, 2023

Abiomed issued the recall because the pumps’ instructions for use do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement.

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Infusion System Replacement Batteries Get FDA Class I Recall

These infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.

Tag: recalls

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