Recall Roundup: October 2025

The FDA gets 2+ million reports of deaths, injuries, and malfunctions associated with medical devices every year.

When these events make up a trend, the device manufacturer and FDA issue a recall for that device, ranging from Class III (least dangerous) to Class I (most dangerous). If you’re a medical provider, you must then follow the manufacturer or FDA’s instructions, whether they tell you to tweak how you use a device or stop using it altogether.

But with so many recalls, it can be hard to keep track! That’s where we come in. We keep you informed on some recent Class I recalls here in our monthly series.

Welcome to October’s Recall Roundup.

Abbott’s advice. Abbott has changed up its catheter packaging design and provided users with additional guidance after reports of some catheter tips detaching while being removed from packaging.

Anesthesia alert. Several lots of Draeger’s Atlan anesthesia workstation may not be properly performing and could fail during mechanical ventilation. Draeger told customers that its representatives would inspect and, if needed, replace the ventilator motor assembly.

App issues. Version v1.15.0 of Dexcom’s G6 and G6 Pro continuous glucose monitoring system Android app had a software defect that could cause the app to shut off unexpectedly. Customers were required to upgrade the app to a new software version. This is the second recall associated with the app in recent months.

Catheter chaos. The FDA issued a recall after Balt USA pulled several lots of its Mega Ballast distal access platform, a type of percutaneous catheter, due to a manufacturing defect.

Dialysis dangers. B Braun Medical warned users to take additional cautions when using its Hemodialysis Bloodlines streamline bloodline set for dialog due to a potential for micro-air bubbles caused by faulty connectors.

Endovascular issues. Certain lots of Cook Medical’s Zenith Alpha 2 thoracic endovascular graft may contain polytetrafluoroethylene (Teflon) coating scrapings, which could release microplastics or PFAS. The company is asking customers to return affected devices.

Impella issue. Johnson & Johnson subsidiary Abiomed sent a letter to customers about cybersecurity vulnerabilities “related to network and physical access” for the operating system in the Automated Impella Controller, according to the FDA. The company said the device can continue to be used but hospitals should restrict access, and a company representative will help them disable its network capabilities. There have been no cybersecurity attacks reported as of Oct. 10, according to an FDA release.

MRI system concern. Several Siemens Healthcare MRI systems have been recalled due to the possibility of ice buildup. MRI machines are kept at temperatures near absolute zero (-452 degrees Fahrenheit) using liquid helium. Siemens told users customer service agents would come and inspect the machines.

Pacemaker update. The FDA issued yet another recall Oct. 10 for several Boston Scientific pacemaker models. This follows a 2024 alert about these ventilators unintentionally entering safety mode, an issue associated with two reported deaths. Boston Scientific released a software fix in August, and this current recall is about two issues related to that change. Providers should still update their software but be aware of the issues, the company said.