- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Affected products (lot / model / serial)
- UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
- Units affected
- 40 packs
- Distribution pattern
- US Nationwide distribution in the state of TX.
- Firm location
- Toano, VA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2964-2026
- Recall initiated
- July 10, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99443
- Last updated on HTM Vibe
- September 8, 2026