FDA-Device2026-06-17Class IIPROCESSING DEFECT
D.O.R.C. TDC VELOCE 23G surgical cutter recalled for loose outer knife
What this means
D.O.R.C. has recalled certain TDC VELOCE 23G Two Dimensional Cutters used in ophthalmic surgery because the outer knife can become loose during use. An increased number of complaints about this issue prompted the recall. No injuries have been reported.
- If you use or manage affected units (check article numbers 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01–K03, 9623.G0201, 9623.G0202, 9623.K0201, or 9311.23G01-00), stop using them immediately.
- Contact D.O.R.C. or your supplier for instructions on replacement or return.
- Verify the lot number on your units against the recall list to confirm whether they are affected.
The agency's original wording
Hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
314 boxes, totaling 1884 units
Manufactured in
Scheijdelveweg 2, N/A, Zuidland, N/A, Netherlands
Products
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2026Want us to check the next one for you?
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