FDA-Device2026-09-23Class IIPACKAGING DEFECT
Bayer MEDRAD Stellant FLEX Syringe Kit recalled for sterilization failure
What this means
Bayer Medical Care has recalled MEDRAD Stellant FLEX Syringe Kits (catalog number FLEXS-150-QFT) used with the Stellant FLEX CT Injection System because some devices may not have been properly sterilized during manufacturing. The recall affects approximately 27,800 kits across the United States.
- Check if you have affected kits (catalog number FLEXS-150-QFT, batch number 8688750).
- Stop using affected kits and contact Bayer Medical Care or your healthcare facility for replacement or return instructions.
- Contact your healthcare provider if you have questions about the impact on any procedures.
The agency's original wording
Hazard
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
27800 kits (556 boxes)
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3147-2026Want us to check the next one for you?
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