FDA Device recall Z-3147-2026
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System by Bayer Medical Care, citing some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3147-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Bayer Medical Care |
| Distribution | US |
Product
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Reason
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Identifiers
| code_info | Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Bayer Medical Care
- Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System
FDA Device · Class II · 2026-06-10 · Bayer Medical Care - Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number:…
FDA Device · Class II · 2023-01-18 · Bayer Medical Care - The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an access…
FDA Device · Class II · 2021-11-10 · Bayer Medical Care - Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL F…
FDA Device · Class II · 2020-12-02 · Bayer Medical Care - MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra W…
FDA Device · Class II · 2019-01-23 · Bayer Medical Care
All Bayer Medical Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3147-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.