Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit
The syringe kit may not be properly sterilized due to a manufacturing issue.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Bayer Medical Care, Inc., of Indianola, Pennsylvania, recalled the MEDRAD Stellant FLEX Syringe Kit used with the Stellant FLEX CT Injection System because some devices may not have been properly sterilized due to a manufacturing sterilization issue. The recall, which began July 31, 2026, involves 27,800 kits (556 boxes) and was added to the FDA's Enforcement Report on September 11, 2026. The kits were distributed nationwide in the US.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the UDI-DI, lot code and catalog code listed under your product.
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX ct Injection System
- UDI-DI
- 00616258022895
- 87078825
- Catalog code
- FLEXS-150-QFT
- Lot
- 8688750
Details
- Company began the recall
- Sold in
US Nationwide distribution.
- Event ID
- 99698
- Recall No.
- Z-3147-2026
- Company
- Bayer Medical Care, Inc.Indianola, Pennsylvania
- Hazard
- Device defect
- Quantity recalled
- 27800 kits (556 boxes)
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Telephone
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
