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Fresenius Kabi Removes Ivenix Large-Volume Pumps

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.

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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.

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Class I Recall Expanded for Alaris Pump Infusion Sets

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

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Fresenius Kabi Removes Ivenix Large-Volume Pumps

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’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

Jul 23, 2025

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.

FDA Issues Early Alert on Infusion Pump Issue from Baxter

Jul 22, 2025

The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.

GE HealthCare Recalls Certain Carestation Devices Over Ventilation Risk

Jun 23, 2025

The Carestation anesthesia systems are being recalled due to a risk of ineffective ventilation in volume control mode, which could lead to serious injury or death.