Recall Roundup: September 2025

Whether you’re a doctor checking on the devices you use, a manufacturer learning from others’ mistakes, or you just like drama, you need to know about recent FDA medical device recalls.

Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected of being linked to medical devices. The agency then issues recalls with corrections ranging from making tweaks to pulling a device off the market.

Healthcare Brew provides a monthly summary of some recent Class I recalls, the most dangerous kind.

Without further ado, here is September’s Recall Roundup!

Bent out of shape. Several components of Medtronic Cardiac Surgery’s DLP left heart ventricle catheter have been recalled because the catheters “may not retain their shape.” Medtronic told users to quarantine affected lots.

Cold-blooded. Some lots of 3M Company’s Ranger blood- and fluid-warming high-flow sets are labeled as being able to warm blood and plasma at high flow rates, when in fact the system can only keep blood and plasma appropriately warm at lower flow rates. The company has communicated the device’s actual abilities to customers and said they should follow those guidelines.

Heart pump hurdle. Abiomed has told users to “quarantine and cease use” of certain brands and product codes of automated Impella controllers because they could lead to decreased performance or even stop the Impella heart pump. This issue has been associated with at least one death, according to an August FDA early alert.

Reprocessing redo. Medline’s medical device reprocessing program, Medline ReNewal, has added to last month’s recall of certain St. Jude Medical’s Response and Supreme electrophysiology catheters. Several more Medline ReNewal’s reprocessed electrophysiology and ultrasound catheters may contain “small residual particulates” that could infect patients or cause other issues.

Software update required. Dexcom has told users to update software on their continuous glucose monitor G7 and One+ iOS, watchOS, and Android apps to the latest version. Past software versions didn’t always alert users when the sensor failed.

Unrealized aspiration. Olympus has told users not to use and to return affected units of its ViziShot 2FLEX (19G) endoscopic single-use aspiration needle because tips could be deformed in an undetected way. There have been 40 reported injuries and a death related to this issue as of Sept. 30, according to the FDA.

Unsterilized. A few of Medline’s “sterile” convenience kits were never actually sterilized, and customers were told to return impacted products.

Wheelchair woes. Permobil is warning users and distributors to “immediately” discontinue the use of the Max Mobility/Permobil SmartDrive MX2+ wheelchair speed control dial. There’s a risk of faulty electrical connection between the controller and the wheelchair’s motor, potentially causing the device to lose control