FDA-Device2026-06-17Class IIPROCESSING DEFECT
D.O.R.C. TDC VELOCE 25G surgical cutter recalled for loose outer knife
OTHERNationwide distribution
D.O.R.C. TDC VELOCE cutter recalled for loose knife risk
The outer knife on D.O.R.C. TDC VELOCE 25G surgical cutters can become loose during use. The company received an increased number of complaints about this issue across multiple lot numbers and article numbers distributed worldwide.
- Check your TDC VELOCE 25G cutter against the affected article and lot numbers listed in the recall notice.
- Contact D.O.R.C. or your distributor for instructions on inspection, repair, or replacement before further use.
- Do not use the device if you suspect the outer knife is loose or unstable.
Hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
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
2068 boxes totaling 12408 units
Manufactured in
Scheijdelveweg 2, N/A, Zuidland, N/A, Netherlands
Products
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2026More D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls
- FDA-Device2026-06-17D.O.R.C. TDC VELOCE 23G surgical cutter recalled for loose outer knife
- FDA-Device2026-06-17D.O.R.C. TDC VELOCE 27G Two Dimensional Cutter recalled for loose outer knife
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