Recall Roundup: November 2025
Issues ranged from leaky anesthesia to insulin notifications.
• less than 3 min read
Caroline Catherman is a reporter at Healthcare Brew, where she focuses on major payers, health insurance developments, Medicare and Medicaid, policy, and health tech.
Whether you’re a medical provider, manufacturer, researcher, or just a person who relishes hearing about other people’s mistakes, you need to know about some of the past month’s FDA medical device recalls.
The FDA categorizes recalls—which can range from small corrections to pulling products from use—from Class III (least dangerous) to Class I (most dangerous). We keep you informed on some of those Class I recalls here in our monthly noncomprehensive roundup series.
Without further ado, welcome to Recall Roundup.
Anesthesia issue. Medline has warned customers to destroy affected lots of its anesthesia circuit kits, plus other convenience kits containing anesthesia circuits, after the company got “multiple complaints” of cracks in the circuit’s expandable tubing. This can cause anesthesia to leak into the operating room, per the FDA.
Infusion pump advisory. Becton Dickinson (BD) is advising customers that if its Alaris infusion pump module 8100 is dropped or “severely jarred,” it needs to be removed, tested, and inspected before it’s reused. BD spokesperson Hallie Nicholson told us there have been two injuries reported in association with this issue.
Insulin issues. The Tandem Diabetes Care Mobi insulin pump’s vibration motor notification system is on the fritz and may potentially stop insulin delivery. Tandem told customers to update to the latest software version.
Perforator problems. In an expansion of a May recall, Integra LifeSciences is asking customers to remove and quarantine more of its Codman disposable perforators for “inadequate welds” that could cause disassembly. There haven’t been any associated injuries or deaths reported, spokesperson Laurene Isip told Healthcare Brew.
(Un)detachable coils. Johnson & Johnson MedTech told customers to stop using and return its Cerepak detachable coil system, which is used to treat brain aneurysms, because the coils might not detach. J&J Medtech spokesperson Erin Farley told Healthcare Brew this “has not led to an increase in reported serious injuries.”
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Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.
Navigate the healthcare industry
Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.