- Recalling firm
- Henry Schein Inc.
- Reason for recall
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Affected products (lot / model / serial)
- Product Codes: 1) 114-3933, Mfr Product Code 1479, Lot Numbers: 2536179, 2606429; 2) 114-3934, Mfr Product Code 1480, Lot Numbers: 2539064; 3) 114-3935, Mfr Product Code 1481, Lot Numbers: 2533123; 4) 114-3937, Mfr Product Code 1482, Lot Numbers: 2533203, 2607170.
- Units affected
- 121 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Barbados.
- Firm location
- Denver, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3015-2026
- Recall initiated
- July 9, 2026
- FDA classification date
- August 25, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99465
- Last updated on HTM Vibe
- September 8, 2026