FDAFDA · Food and drugs·Recall number Z-3147-2026
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Published September 23, 2026 · Recall initiated: July 31, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Bayer Medical Care, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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