Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

On or about July 31, 2026, consignees were notified via telephone followed by sending URGENT MEDICAL DEVICE RECALL letters. Actions to be taken: 1. Review your inventory for affected product and to quarantine any loose/unboxes product from the lot. 2. Whether or not Box 0855 of Lot 8688750 is found to be in your inventory/possession, we will need you to please confirm that information for our records by filling out and returning the response form provided. 3. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.

• FDA enforcement recordOfficial FDA database entry for Z-3147-2026
• FDA 510(k) clearance · K182273The device's official FDA premarket clearance record
• FDA device classification · DXTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Bayer Medical Care, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.