Recall Roundup: September 2026

Each year, the FDA receives more than 2 million reports of deaths, injuries, and malfunctions suspected to be associated with medical devices.

Some of these reports spark manufacturer action and official FDA recalls, labeled in severity from Class III (least dangerous) to Class I (most dangerous). Each month, we share recent Class I recalls in this monthly series to keep healthcare providers informed.

Welcome to Recall Roundup!

Attachment issues. There have been 184 serious injuries associated with Medtronic and subsidiary Given Imaging’s Bravo CF esophageal pH monitoring capsule delivery device. Capsules may not properly detach from the device, or they may fail to attach to patients’ esophaguses, per a Sept. 11 notice on an FDA recall database. Customers can return unused devices to Medtronic for replacement, per the database. Medtronic did not respond to a request for comment by deadline.

CPAP concerns. The FDA posted a Sept. 18 recall for some lots of CooperSurgical’s INCA neonatal nasal CPAP sets. The manufacturer warns that some units may “exhibit a loose connection” between the flexible tubing and the nasal cannula, potentially leading to leakage and reducing treatment effectiveness, according to the FDA.

More trouble. BD ChloraPrep applicators are present in a number of convenience kits from Medline and Owens & Minor subsidiary Avid Medical. These applicators have been recalled. Owens & Minor did not respond to a request for comment by deadline.

Patient mix-ups. Nova Biomedical’s StatStrip glucose and b-ketone meter may sometimes display a past patient’s information for the current patient. If the person doing the testing doesn’t notice this glitch, test results are then connected to the wrong patient’s medical record. Nova is working on a firmware fix, according to a Sept. 11 FDA database entry. In the meantime, the company advises users to double-check patient information when using this device, the FDA said.

Heart pump problems. The FDA posted a recall on Sept. 16 for Abiomed’s automated Impella controllers in connection with a suspected problem with a device component called a purge flag. As of Aug. 17, Abiomed has reported 37 serious injuries and three deaths in association with this issue. Abiomed will replace the potentially defective device components, and in the meantime, the devices can continue to be used “to ensure continuity of care,” according to an FDA notice that is current as of Sept. 24.

Recalls keep coming. Another round of companies have noted that some of their medical convenience kits contain sodium chloride ampules manufactured by Huons Co. The ampules were recalled after the kits were assembled and should not be used, though other kit components can still be used. This includes certain kits and procedure trays from Medical Action Industries; Becton, Dickinson and Company (BD); and Owens & Minor subsidiary Avid Medical.