Recall Roundup: March 2026

Welcome to Recall Roundup, where we keep you updated on last month’s FDA medical device recalls.

FDA recalls occur when a device is defective or poses a potential health risk. Either an issue needs to be corrected, or the device needs to be pulled from the market altogether. Recalls are ranked by severity from Class III (least dangerous) to Class I, which means the defect poses a high risk of serious injury or death.

We’ve included some of March’s most serious Class I recalls below. Now, let the Recall Roundup commence!

Catching a breath. Some Philips Respironics ventilators may not deliver enough air to a patient when used with a non-pneumatic nebulizer. The company told users on March 2 to stop using non-pneumatic nebulizers with their Trilogy Evo Platform ventilators and take other steps, too, like updating software.

Cryoprobe crisis. There have been at least five serious injuries reported after Erbe USA’s flexible cryoprobes ruptured during activation. These devices are used to freeze and destroy tissue inside a patient. Erbe USA told customers to stop using these products in a Feb. 12 letter.

Getting heated. Navajo Manufacturing Company’s Handy Solutions Neck and Shoulders Heating Pad isn’t always very handy. In fact, when the pad is folded or placed under a patient’s body, it can overheat to the point that it burns. There have been four serious injuries reported in connection with this issue as of March 10. Navajo told affected customers in February to cut cords and trash their pads.

Heart pump control concern. An alarm display on some of Abiomed’s automated Impella controllers might be delayed when using first-generation Impella 5.5 pumps. Abiomed warned customers on Feb. 16 not to use an automated Impella controller with that generation of heart pumps unless the controller’s software has been updated.

Splittable sheath introducer issue. Merit Medical Systems has pulled a medical device called a 16F dual-valved splittable sheath introducer, which is used to place hemodialysis catheters in a patient. The reason for its removal? It doesn’t always split properly. In a Feb. 5 letter, Merit told customers that an undisclosed number of patients have been injured and advised destroying the product.