Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
- Recalling company
- Bayer Medical Care, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 31, 2026
- Reported
- Sep 23, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 27800 kits (556 boxes)
- Lot / codes
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Company location
- Indianola, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3147-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3147-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.