- Recalling firm
- Davol, Inc.
- Reason for recall
- Potential for product to contain foreign matter, confirmed to be inspect fragments.
- Affected products (lot / model / serial)
- Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
- Units affected
- 1,622 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of China, South Korea.
- Firm location
- Warwick, RI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1896-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- April 21, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98602
- Last updated on HTM Vibe
- July 24, 2026