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Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.

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Zyno Medical Recalls Infusion Pumps Over Software Issue

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

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Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

Johnson & Johnson Megadyne Electrodes Nab Class 1 Recall

Jul 13, 2023

The FDA has labeled the recall of two types of Megadyne electrodes manufactured by Johnson & Johnson’s Ethicon as a class I, the most serious.

Infusion System Replacement Batteries Get FDA Class I Recall

May 22, 2023

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.

Fresenius Kabi Recalls Ivenix Infusion System

Apr 25, 2023

Fresenius Kabi has issued a voluntary recall of the Ivenix Infusion System due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.