Z-3147-2026 Class II Ongoing
FDA device recall Z-3147-2026 was initiated by Bayer Medical Care, Inc. on July 31, 2026 and is designated Class II. Reason for recall: Some devices may not have been properly sterilized due to a manufacturing sterilization issue. The recall status is ongoing. Affected quantity: 27800 kits (556 boxes).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27800 kits (556 boxes)
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;