Z-2323-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2068 boxes totaling 12408 units
Product Description
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Reason for Recall
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Distribution Pattern
Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.
Code Information
1. Article Number: 9268.VIT25; UDI-DI: 08717872031873; 2. Article Number: 9311.25G01; UDI-DI: 08717872035116; 3. Article Number: 9311.25G02; UDI-DI: 08717872035345; 4. Article Number: 9311.25K01; UDI-DI: N/A; 5. Article Number: 9311.25K02; UDI-DI: N/A; 6. Article Number: 9311.25K03; UDI-DI: N/A; 7. Article Number: 9625.G0201; UDI-DI: N/A; Lot Numbers: 101118001, 101799001, 101800001, 102675001, 102676001, 103507001, 103508001, 103509001, 104360001, 50489-*-*-1, 54992-*-*-1, 54993-*-*-1, 54994-*-*-1, 56251-*-*-1, 56254-*-*-1, 56255-*-*-1, 56256-*-*-1, 56257-*-*-1, 57683-*-*-1, 58588-*-*-1, 58589-*-*-1, 60300-*-*-1, 65315-*-*-1, 65316-*-*-1, 65317-*-*-1, 65318-*-*-1, 65319-*-*-1, 65320-*-*-1, 65321-*-*-1, 65322-*-*-1, 66818-*-*-1, 70551-*-*-1, 70552-*-*-1, 70565-*-*-1, 70566-*-*-1, 70567-*-*-1, 71803-*-*-1, 71804-*-*-1, 71805-*-*-1, 71806-*-*-1, 75717-*-*-1, 76191-*-*-1, 76516-*-*-1, 76806-*-*-1, 76807-*-*-1, 76808-*-*-1, 76852-*-*-1, 76853-*-*-1, 76854-*-*-1, 76855-*-*-1, 77374-*-*-1, 77375-*-*-1, 77501-*-*-1, 77502-*-*-1, 77503-*-*-1, 77504-*-*-1, 77505-*-*-1, 78097-*-*-1, 78098-*-*-1, 78110-*-*-1, 78111-*-*-1, 79425-*-*-1, 79426-*-*-1, 81292-*-*-1, 81293-*-*-1, 81681-*-*-1, 82172-*-*-1, 82173-*-*-1, 82174-*-*-1, 82326-*-*-1, 82702-*-*-1, 82703-*-*-1, 82704-*-*-1, 82778-*-*-1, 83543-*-*-1, 83544-*-*-1, 84535-*-*-1, 84536-*-*-1, 84537-*-*-1, 85411001, 85412001, 86024001, 86025001, 86026001, 86806001, 86807001, 87173001, 87174001, 87175001, 87390001, 87950001, 88204001, 88205001, 88552001, 88616001, 89535001, 90377001, 90378001, 90379001, 91280001, 91281001, 92631001, 92633001, 95437001, 99667001;