FDAFDA recall Z-3147-2026 · Sep 23, 2026
Bayer Medical Care, Inc.: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall
Recall found
Product
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Reason for recall
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Quantity
- 27800 kits (556 boxes)
- Distribution
- US Nationwide distribution.
- Recalling firm
- Bayer Medical Care, Inc., Indianola, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-31
Source: openFDA enforcement record Z-3147-2026 · search recall number Z-3147-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.