MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall (Bayer Medical Care, Inc.)
Medical deviceClass IIOngoing
Summary: Bayer Medical Care, Inc. is recalling 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.
What is being recalled
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Why
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3147-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 31, 2026 |
| Reported | September 23, 2026 |
| Company | Bayer Medical Care, Inc. |
| Company location | Indianola, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 27800 kits (556 boxes) |
More recalls from Bayer Medical Care, Inc. · all medical device recalls · recalls from July 2026