- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Affected products (lot / model / serial)
- 1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393;
- Units affected
- 59
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, FL, MD, NE, 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-0094-2027
- Recall initiated
- August 10, 2026
- FDA classification date
- October 7, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99808
- Last updated on HTM Vibe
- October 21, 2026
