FDA Announces Class I Recall for Medtronic Esophageal pH Monitoring Devices

The U.S. FDA has issued a Class I recall, its most serious classification, for specific Medtronic and Given Imaging esophageal pH monitoring capsule delivery devices. This recall indicates that using these devices could lead to serious injury or death. Affected devices with expiration dates up to and including October 20, 2027, are to be removed from use or sale. Medtronic advised customers on August 6, 2026, to identify and quarantine these devices for replacement.