CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
TDC Veloce" Two Dimensional Cutter - 20k CPM recalled
D.O.R.C. Dutch Opthalmic Research Center Intl is recalling TDC Veloce" Two Dimensional Cutter - 20k CPM, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2322-2026
- FDA event ID
- 98814
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl, Zuidland, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +36 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Product as listed by the FDA
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;
Where it was distributed
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.
Questions about this recall
Why was it recalled?
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Which lots are affected?
1. Article Number: 9268.VIT23; UDI-DI: 08717872031866; 2. Article Number: 9311.23G01; UDI-DI: 08717872035109; 3. Article Number: 9311.23G02; UDI-DI: 08717872035338; 4. Article Number: 9311.23K01; UDI-DI: N/A; 5. Article Number: 9311.23K02; UDI-DI: N/A; 6. Article Number: 9311.23K03; UDI-DI: N/A; 7. Article Number: 9623.G0201; UDI-DI: N/A; 8. Article Number: 9623.G0202; UDI-DI: N/A; 9. Article Number: 9623.K0201; UDI-DI: N/A; 10. Article Number: 9311.23G01-00; UDI-DI: 08717872035307; Lot Numbers: 100637001, 57682-*-*-1, 64312-*-*-1, 69017-*-*-1, 73237-*-*-1, 74225-*-*-1, 75735-*-*-1, 79460-*-*-1, 80338-*-*-1, 80963-*-*-1, 81335-*-*-1, 81679-*-*-1, 82213-*-*-1, 82325-*-*-1, 82742-*-*-1, 82779-*-*-1, 83584-*-*-1, 84580-*-*-1, 85451001, 86069001, 86798001, 86799001, 87205001, 88231001, 91957001, 92629001, 92630001, 93336001, 94351001, 95436001, 95462001, 96097001, 96123001, 97279001, 97789001, 98643001, 99130001, 99185001, 99697001;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98814| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide | |
| CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
More recalls from D.O.R.C. Dutch Opthalmic Research Center Intl
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
| Device | CLASS II | TDC Veloce" Two Dimensional Cutter - 20k CPM recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
| Device | CLASS II | Directional Laser Probe with Alcon / Lumenis connector recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
| Device | CLASS II | Directional Laser Probe with Alcon / Lumenis connector recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
| Device | CLASS II | Directional Laser Probe with Alcon / Lumenis connector recalled | D.O.R.C. Dutch Opthalmic Research Center Intl | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |