Recall Roundup: August 2026

Welcome to Recall Roundup!

Each month, we compile a list of recent medical device removals and corrections that the FDA has designated as Class I recalls.

The FDA divides medical device recalls into three severity levels, and Class I is the most dangerous. These recalls are frequently associated with reports of serious injuries or deaths, though the FDA says the reports do not inherently establish a cause-and-effect relationship between a device and an injury.

Let’s get started.

Bubble trouble. Some lots of Baxter Healthcare’s Duo-Vent solution sets and male Luer lock adapters may contain air bubbles in the drip chamber and tubing. For some vulnerable patients, these air bubbles could lead to a stroke or heart attack, though no serious injuries or deaths have been reported as of July 15, according to the FDA. Baxter said it will replace the recalled products.

Catheter caution. Boston Scientific is pulling some lots of its Enroute Transcarotid Neuroprotection System products. At least one serious injury was reported amid complaints about the product’s tip partially or fully separating during use. Affected lots can be returned for credit, according to an FDA database entry.

Leading the way. Boston Scientific is asking customers to return unused Infinion CX leads for its spinal cord stimulator system. A June 17 field safety notice from Boston Scientific said the leads fractured 1% of the time from Sept 2014 through April 2026. The FDA labeled this a Class I recall on Aug. 5.

Needle kit issue. Becton Dickinson (BD) has recalled certain lots of its intraosseous vascular access system needle sets in response to reports that part of the kit—a component called an obturator—was difficult to remove. Forty-five serious injuries and four patient deaths were reported in association with this issue as of July 22. BD asked customers to destroy all unused sets. It has since “acquired new molds with improved dimensional controls,” per an FDA recall database entry.