FDA DevicesClass II
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27,...
Published: June 17, 2026Recall ID: Z-2324-2026Category: devicesCountry: US
Reason for Recall / Hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Product Description & Identification
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Affected Products
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Additional Source Details
| Field | Value |
|---|---|
| City | Zuidland |
| State | N/A |
| Event id | 98814 |
| Address 1 | Scheijdelveweg 2 |
| Address 2 | N/A |
| Code info | 1. Article Number: 9268.VIT27; UDI-DI: 08717872031880; 2. Article Number: 9311.27G01; UDI-DI: 08717872035123; 3. Article Number: 9311.27G02; UDI-DI: 08717872035352; 4. Article Number: 9311.27K01; UDI-DI: N/A; 5. Article Number: 9311.27K02; UDI-DI: N/A; 6. Article Number: 9311.27K03; UDI-DI: N/A; 7. Article Number: 9627.G0101; UDI-DI: N/A; 8. Article Number: 9627.G0201; UDI-DI: N/A; 9. Article Number: 9311.27G01-00; UDI-DI: 08717872035321; Lot Numbers: 202511001, 202601070, 51682-*-*-1, 51683-*-*-1, 54025-*-*-1, 54995-*-*-1, 56258-*-*-1, 56259-*-*-1, 64307-*-*-1, 64310-*-*-1, 69018-*-*-1, 75718-*-*-1, 76781-*-*-1, 76810-*-*-1, 77842-*-*-1, 79461-*-*-1, 80339-*-*-1, 80964-*-*-1, 81336-*-*-1, 82214-*-*-1, 82743-*-*-1, 83585-*-*-1, 84581-*-*-1, 85452001, 86070001, 87206001, 90383001, 97231001; |
| Postal code | N/A |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 261 boxes totaling 1566 units |
| Reason for recall | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | Letter |
| Center classification date | 20260605 |
Overview
- Recalling FirmD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.