Category: Recalls

Recalls

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

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.

Recalls

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Recalls

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.

Medtronic Recalls Certain Newport Ventilators and Related Service Parts

Jun 18, 2025

Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.

Zyno Medical Recalls Infusion Pumps Over Software Issue

Jun 18, 2025

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection

Jun 5, 2025

Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.

Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk

Jun 5, 2025

The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.

FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls

Jun 4, 2025

Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.

Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise

May 29, 2025

While total recalls and units affected declined in Q1 2025, the number of Class I events increased.

Recalls

Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk

Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.