- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
- Affected products (lot / model / serial)
- Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.
- Units affected
- 56 kits
- Distribution pattern
- US Nationwide distributor in the state of Arizona.
- 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-0282-2027
- Recall initiated
- September 8, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99968
- Last updated on HTM Vibe
- November 3, 2026
