Recall Roundup: December 2025

December 2025 was a month full of holidays, time with loved ones—and, most importantly, medical device recalls.

The FDA gets 2+ million reports of deaths, injuries, and malfunctions associated with medical devices every year. Sometimes, these events prompt a recall ranging from Class III (least dangerous) to Class I (most dangerous). These recalls contain instructions that can range from small corrections to ending a device’s distribution.

We keep you informed on some recent Class I recalls here in our monthly series. Without further ado, welcome to the final Recall Roundup of 2025!

Anesthesia anomaly. Some power management boards for GE HealthCare Carestation 600 and 700 series anesthesia systems are at risk of unexpected shutdown. GE gave users special instructions on how to continue to use the anesthesia systems despite this issue and how to troubleshoot if the device shuts down.

Cracking up. Cracks were reported to be emerging in the hose of some catheter mounts for specific lots of several models of Draeger’s ErgoStar CM, which connects a breathing system to a mechanically ventilated patient. Affected, unused products should be returned to Draeger, the FDA recall says.

Draeger’s danger. Some of Draeger’s Vapor 3000 unheated calibrated anesthetic vaporizers contain “impurities,” according to the FDA. These vaporizers work by evaporating liquid anesthetic into gas so it can travel to a patient. Draeger is recommending affected vaporizers be replaced before use.

Eyeing a potential issue. Some lots of Alcon Laboratories’s Custom Pak ophthalmic procedure packs may not have been properly sealed, compromising sterility. Alcon told users to trash any unused affected packs, which contain sterile surgical procedure tools, and said it will provide replacements.

Infusion issues. One lot of the Ivenix Infusion System’s large volume pump primary administration set was assembled incorrectly. Manufacturer Fresenius Kabi has urged those who received that defective lot to stop use, destroy, or return their devices.

Infusion issues, continued. Thought we were done with Fresenius Kabi’s infusion system? Think again. The system had an additional recall in December, this time caused by a software issue. Software versions 5.10.1 and earlier have “anomalies that have the potential to cause serious patient harm or death,” per the FDA’s recall database. Fresenius Kabi told users to install the newest Ivenix infusion management system and large volume pump software versions.