Category: Recalls

Recalls

FDA Classifies Draeger VentStar Resus Neo Breathing Circuit Recall as Class I

Cracks in disposable infant breathing hoses could cause restricted ventilation, hypoxia, or death, prompting the agency's most serious recall designation.

Recalls

FDA Issues Alert for Heart Pump Controllers Due to Component Failures

Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.

Recalls

React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

Recalls

FDA Classifies Draeger VentStar Resus Neo Breathing Circuit Recall as Class I

Cracks in disposable infant breathing hoses could cause restricted ventilation, hypoxia, or death, prompting the agency's most serious recall designation.

Fresenius Kabi Removes Ivenix Large-Volume Pumps

Jan 6, 2026

A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.

Baxter Removes Sigma Spectrum Infusion System Platforms

Jan 6, 2026

The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.

Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking

Dec 30, 2025

The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.

FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue

Dec 29, 2025

The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.

FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices

Dec 22, 2025

Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.

BD Advises Biomed Inspection of Dropped Alaris Pump Modules

Dec 22, 2025

The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.

Recalls

GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk

GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.