Recall Z-3147-2026
Bayer Medical Care, Inc. · initiated July 31, 2026
Product
MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Codes / lots: Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Reason for recall
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-3147-2026
- Initiated
- July 31, 2026
- Posted by FDA
- September 11, 2026
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 27800 kits (556 boxes)
- Distribution
- US Nationwide distribution.
- Recalling firm
- Bayer Medical Care, Inc., Indianola, PA