- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
- Affected products (lot / model / serial)
- Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
- Units affected
- 112 kits
- Distribution pattern
- U.S. Nationwide distribution in the state of California.
- Firm location
- Toano, VA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2772-2026
- Recall initiated
- May 19, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99250
- Last updated on HTM Vibe
- August 4, 2026