Recall Roundup: October 2026

Each year, the FDA receives more than 2 million reports of deaths, injuries, and malfunctions suspected to be associated with medical devices. In some cases, the agency issues a recall. These are grouped into three classes based on potential risk to patients. We recap last month’s Class I recalls—the most dangerous—here.

Welcome to October’s Recall Roundup!

Diagnostic ultrasound correction. Philips Ultrasound has reported eight serious injuries and four deaths associated with its Lumify diagnostic ultrasound system as of Sept. 29. The device sometimes requires users to re-register before it can be used, and users in areas without wifi or cell service can’t do that, locking them out. In addition, there may be connectivity issues with customer tablets and phones. Philips sent affected customers a letter on Sept. 24 advising them to only use the system in areas with wifi and cell service unless they have a backup device present. The company is developing a software fix and searching for the cause of the connection issue, per an FDA notice current as of Oct. 19.

Disposable breathing circuit dangers. Draeger warned users to inspect its VentStar Resus Neo hoses for cracks or detachment before using them and to throw out any hoses with those defects, according to an FDA recall posted on Oct. 1. The company said it has received reports of cracked hoses, but luckily the cracks had been noticed before the device was used. There have been no serious injuries or deaths reported by the manufacturer as of Sept. 3.

False alarm. Certain Tandem Mobi insulin pumps from Tandem Diabetes Care may give off false occlusion alarms and suspend insulin flow even when a suspension isn’t necessary. A Sept. 23 notice to customers gives troubleshooting guidance.

Heart pump problems. Some units of Abiomed’s Automated Impella Controller, which controls a catheter-based heart pump, require hardware, firmware, or software updates based on a company review of servicing records, per a Sept. 18 letter to customers. The devices can continue to be used until the company can service them, according to the letter.

Immunoassay inaccuracy. An automated laboratory test called the HemosIL AcuStar HIT-IgG(PF4-H) may give out false negatives, per an FDA recall posted Oct. 10. The test is used to help determine the risk of heparin-induced thrombocytopenia, a life-threatening complication that can occur after some patients take the blood thinner heparin. Manufacturer Instrumentation Laboratory has told users to destroy affected lots and find a different testing method.

Ventilator shutdown. Certain ventilator devices from React Health may experience system reboots that interrupt ventilation therapy or recurring System Fault 10 alarms, the company warned customers in a Sept. 17 letter. React Health recommended using backup ventilation as needed and reaching out to the company for a fix if this occurs.