- Recalling firm
- Bayer Medical Care, Inc.
- Reason for recall
- Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Affected products (lot / model / serial)
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Units affected
- 27800 kits (556 boxes)
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Indianola, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Telephone
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3147-2026
- Recall initiated
- July 31, 2026
- FDA classification date
- September 11, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99698
- Last updated on HTM Vibe
- September 29, 2026