Recall Roundup: July 2026

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

Each month, we compile a list of recent medical device removals and corrections the FDA has designated as Class I recalls. This class means the defect, if unaddressed, has a “reasonable probability” of seriously injuring or killing a patient, according to the agency’s website.

Let the July roundup commence!

Abiomed issue. Abiomed and Oscor have flagged potential sheath leakage from their 14Fr and 23Fr introducers, which are used to insert and remove catheters. As of April 22, Abiomed has reported eight associated instances of major bleeding and three complaints that correspond with patient deaths, though Abiomed concluded the deaths are not due to introducer leakage, according to the FDA.

Catching a breath. As of May 21, Baxter Healthcare Corporation has reported one serious injury associated with air and medication leakage from its Volara System single-patient-use circuit kit, a positive pressure breathing device. All devices distributed on or after April 28, 2025, are under recall. The company is advising users to make sure the device’s nebulizer cup is securely locked and inspect it for damage before and during use. More nebulizer cups and patient circuits are available.

Catheter caution. Medtronic has asked users to quarantine and return certain lots of its Harmony delivery catheter system because of potential increased risk of distal tip detachment.

Prep pad problem. Windstone Medical Packaging, doing business as Aligned Medical Solutions, is warning customers to discard Webcol large alcohol prep pads that are included in certain lot numbers of some of its surgical convenience kits. Manufacturer Cardinal Health recalled those prep pads in March due to potential microbial contamination, according to the FDA.

Ventilator recall. Certain ResMed Astral 100 and Astral 150 ventilators have a component called a supercapacitor that may leak over time, potentially damaging the device’s charger chip and triggering a fail-safe that pauses therapy. This issue has been associated with five serious injuries as of June 23, according to ResMed. There’s a limited supply of replacement parts, so ResMed has recommended physicians and patients continue using these ventilators until replacement parts become available. In the meantime, take precautions like having backup ventilation equipment.