Recall Roundup: February 2026

Paging all healthcare professionals: Welcome to Recall Roundup, where we keep you updated on some of the most serious FDA medical device recalls from the last month.

Recalls range from making tweaks to pulling a device from the market altogether. First, the manufacturer takes action, then the FDA decides whether that action should be labeled a recall. The recalls are ranked from Class III (least dangerous) to Class I (most dangerous).

Let’s get into it.

Feeling pressure. Olympus sent a Jan. 16 letter warning customers to stop using certain models of its high-flow insufflation unit. The units’ software has an algorithm that could cause overpressure, which can lead to air embolisms, cardiac arrest, or death. As of Dec. 31, Olympus has reported two serious injuries but no deaths related to this issue.

Pump problems. Abiomed’s Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist heart blood pumps have a differential pressure sensor that may malfunction, potentially causing the device to display incorrect information. As of Jan. 15, Abiomed has reported 22 serious injuries, per a Feb. 3 FDA press release. Abiomed said in a Jan. 27 letter the product can still be used but released additional instructions and precautions that providers should take.

Reprocessing redo. Some of Medline Industries’s reprocessed catheters may be contaminated with “small particles of residual material” that could cause complications like infection. Medline’s reprocessing division told users about this issue in mid-2025 but extended the warning to include more item numbers and lots in a Dec. 22 letter. The manufacturer is asking customers to destroy affected devices for credit.

Stents getting stuck. Boston Scientific has reported 167 serious injuries and three deaths as of Dec. 23 in association with certain Axios stents and electrocautery-enhanced delivery systems. Some of the stents are not properly deploying or expanding, potentially prolonging surgery or even requiring additional surgery, per the FDA. Stents that are already implanted should be fine, but providers shouldn’t implant any new stents from the affected lots.