FDA Medical Device Recalls (openFDA)
Bayer Medical Care, Inc.: MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- Recall number
- Z-3147-2026
- Recalling firm
- Bayer Medical Care, Inc.
- Product
- MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-09-11
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- 510(k) numbers
- ["K182273"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28