Are you curious about all the ways multimillion-dollar medtech can go wrong?
If so, welcome to Recall Roundup, where we keep our eyes on the FDA’s recent medical device recalls.
First, a company takes action, then the FDA categorizes that action as a recall from Class III (least dangerous) to Class I (most dangerous) and summarizes those recalls in weekly enforcement reports, which also include early alerts for things that may be recalled later on.
Without further ado, below is a noncomprehensive list of recent Class I recalls.
Applicator issue. Getinge subsidiary Maquet Critical Care AB has updated instructions for all of its Servo-u, Servo-n, and Servo-u MR ventilators due to an error that could result in a difference between the volume of oxygen delivered and the volume displayed.
Arterial cannula recall. Edwards Lifesciences has pulled several lots of its OptiSite arterial perfusion cannula, a device used during cardiopulmonary bypass procedures, as there have been a few instances where a wire separates from the device.
Capsule crisis. Medtronic has pulled certain lot numbers of the Bravo CF capsule delivery device, which delivers a capsule that monitors the pH of a patient’s esophagus. But a misapplied adhesive on the delivery device sometimes keeps the capsules from properly and safely attaching, the FDA reported.
Heart pump hiccup. Abiomed updated instructions for the controller to its Impella heart pump. The manufacturer said sometimes the control doesn’t detect the pump when it connects.
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Infant breathing circuit issue. AirLife and Vyaire are pulling AirLife infant heated wire circuits, used to support ventilation, because they can potentially disconnect unexpectedly, according to the recall.
Infusion pump issue. Baxter Healthcare Corporation gave customers new instructions for its Novum IQ large volume pumps after reports of over and underinfusions of fluids.
Laryngoscope recall. Certain lot numbers of Intersurgical’s i-view video laryngoscope are being pulled because of a potential for the devices’ batteries to become depleted, resulting in faulty performance, the FDA reported.
Patient lift problems. An optional component for machines that lift patients up might not attach properly, risking patients falling to the ground. Baxter Healthcare Corporation warned consumers to not use the part.
Rainbow tape recall. Some versions of AirLife’s Broselow Rainbow Tapes—a color-coded tape that provides treatment recommendations based on a child’s height and weight—have incorrect measurement values, the company reported in its recall.
Correction 08/05/2025: This story has been updated to clarify that Baxter Healthcare Corporation gave customers mitigating instructions for using its recalled Novum IQ large volume pumps; the company did not warn users to discontinue use, as stated in the original story.