TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Recall Z-2323-2026 · Posted 2026-06-05
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Recalling FirmD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Recall StatusOpen, Classified
Product CodeHQE
Date Initiated2026-04-30
Product Quantity2068 boxes totaling 12408 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.
Firm Action
On April 30, 2026 Urgent Medical Device Recall letters were sent to customers. Actions to be taken:
Review this Product information as soon as possible with relevant members of your staff.
1. Pass this FSN as soon as possible on to all those who need to be aware of it, including other locations, organizations and/or customers who might have received the impacted Product(s) through you.
2. If you have the affected Products and the affected lots (see attachment below) in your
inventory, remove and return them to DORC following the instructions in the attachment.
3. Follow the instructions on how to complete and submit the Field Action Acknowledgement Form that is provided with this FSN.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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