Recall Z-3147-2026 ยท DXT Injector And Syringe, Angiographic
Bayer Medical Care, Inc.
MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
| Date | Sep 11, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| Reason | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 27800 kits (556 boxes) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc., Nov 1, 2018 |