Recall Roundup: May 2026

Welcome to Recall Roundup, our monthly must-read for anyone who ever uses or purchases medical devices.

FDA recalls occur when a device is defective or poses a potential health risk. The FDA ranks them in severity from Class III (the least dangerous) to Class I, meaning the defect has a decent chance of seriously injuring or killing a patient.

Without further ado, here’s our roundup of May’s Class I recalls.

Cracked catheters. In an April 2 letter to customers, Cook Medical recalled several lots of sizing catheters—single-use catheters with gold marker bands—because they’re at an increased risk of cracking or breaking. Customers are being asked to return affected products to Cook.

Fired up. Ventec, doing business as React Health, warned customers in a March 23 letter that there are certain circumstances where its VOCSN V+Pro home-use ventilator package and unit might leak oxygen, potentially leaving patients without enough air and putting oxygen-enriched areas at a higher risk of a fire. It should be removed from where it is used or sold.

Injection issue. Some Medline kits include bupivacaine hydrochloride in dextrose injections that were manufactured by South Korea-based pharmaceutical company Huons Co. The FDA flagged “quality issues” with these injections, including some complaints about efficacy. Medline warned customers on April 10 that they should identify and isolate affected kits, and the company will supply labels advising users to remove and discard that part of the kit.

Stapler situation. Intuitive Surgical has reported, as of Feb. 23, four serious injuries and one death associated with a surgical stapler reload for its curve-tipped stapler, where the reload may not be completely stapling blood vessels shut. The company urged users to stop using affected products. The FDA published an early alert about this recall in March.

Syringe switch up. Omnicell has warned customers to stop using new syringe label rolls for its I.V. Station, a device that’s used to automate the preparation and compounding of IV medications and to label those medications. The company said the automated device isn’t working consistently with these labels, potentially leading to mislabeled syringes.