Recall Roundup: June 2026

The FDA receives more than 2 million reports of deaths, injuries, and malfunctions thought to be associated with medical devices every year.

Some of these suspicions are serious enough for the agency to issue an official recall. Recalls, which are typically voluntary, are not all the same. They can refer to pulling a device from the market, or modifying an existing product to improve its safety. These recalls are labeled from Class III (least dangerous) to Class I (most dangerous).

It’s crucial for nurses, doctors, and healthcare executives to keep track of recalls. That’s where we come in!

Welcome to Recall Roundup, our monthly series highlighting some of the past month’s new Class I medical device recalls.

Anesthesia update. Draeger is expanding a 2024 correction for its anesthesia workstations to include additional Atlan A350 and A350 XL models. As previously reported, a manufacturing error may cause mechanical ventilation to fail. Draeger is contacting customers to arrange repairs. Until then, the devices should be used under “constant supervision,” per an FDA release.

Impella issues. Abiomed has updated user instructions for its automated Impella controller because of a potential software error that occurs when the controller is used with left ventricular Impella devices. Abiomed has reported two serious injuries and a death associated with this heart pump issue as of April 27.

Infant resuscitation system correction. GE HealthCare Giraffe and Panda infant resuscitation systems and warmers may deliver too much or too little oxygen if they contain a M1091607-R blender. GE recommends not to use devices with these blenders until they can be repaired. If use is necessary, follow additional recommended precautions.

Recall reaches far. Medical kits and sets from companies including Arrow International, B Braun Medical, and Medline contain certain recalled products from South Korea-based pharmaceutical company Huons Co. As we reported in last month’s roundup, an FDA inspection found quality issues with several of the company’s injectable products.