Recall roundup: FDA medical device recalls during June 2025

Are you curious about all the ways that multimillion-dollar medtech can go wrong?

If so, you’re in the right place!Welcome to Recall Roundup, a noncomprehensive roundup of recent FDA Class I recalls—the most severe and potentially life-threatening kind. Recalls range from correcting an issue to removing a device from the market altogether.

With that, let’s get into it!

Blood products administration set recall. Fresenius Kabi has pulled an incorrectly assembled line of its Ivenix LVP Blood Products Administration Set. If used, patients could be infused with unfiltered blood.

Catheter tip issue. Cook Medical wants customers to return certain Cook Beacon Tip 5.0 Fr angiographic catheters because the tip is at risk of detaching.

Convenience kit recall. Medline told customers to stop using and destroy certain lots of neonatal and pediatric convenience kits that contain recalled Smiths Medical endotracheal tubes. The company said the tubes are too small and could cause underventilation.

Glucose receiver error. Some Dexcom G6, G7, One, and One+ glucose receivers with certain serial numbers may have receivers that weren’t correctly assembled and should be returned.

Infusion system issue. Zyno Medical asked customers to stop using certain lots of its Z800WF Infusion System because “unreleased software versions” were installed “without verification or validation.”

Ventilators on the fritz. Medtronic is asking customers to replace certain models of its Newport HT70 series ventilators and control boards. They have defects that can cause the ventilator to shut down during use or otherwise malfunction.