TDC VELOCE 23 gauge vitrectomy cutters may have loose outer knife
TDC VELOCE 23G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a cutting component may loosen during an eye procedure, a risk of harm with no injuries reported in the source.
Plain-English summary
The TDC VELOCE 23G Two Dimensional Cutter - 20k CPM is being recalled across article numbers 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201 and 9311.23G01-00. The action covers 314 boxes totalling 1,884 units.
The stated reason is an increase in the incidence of complaints of a loose outer knife, with reports of the outer knife becoming loose during use. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and to Australia, Austria, Belgium, Bulgaria and other markets. The cutters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the article numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- 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;
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 6. Article Number: 9311.23K03
- 7. Article Number: 9623.G0201
- 8. Article Number: 9623.G0202
- 9. Article Number: 9623.K0201
- 10. Article Number: 9311.23G01-00
- UDI-DI: 08717872035307
- Lot Numbers: 100637001
- 57682-*-*-1
- 64312-*-*-1
- 69017-*-*-1
- 73237-*-*-1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by D.O.R.C. Dutch Opthalmic Research Center Intl B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
See all →- HighTDC VELOCE 27 gauge vitrectomy cutters may have loose outer knife
FDA (Devices) · 2026-06-17
- HighTDC VELOCE 25 gauge vitrectomy cutters may have loose outer knife
FDA (Devices) · 2026-06-17
- HighDirectional Laser Probe Recalled for Fiber Extension and Direction Failure
FDA (Devices) · 2024-03-27
- HighDirectional Laser Probe Recall Due to Fiber Extension and Direction Malfunction
FDA (Devices) · 2024-03-27
- HighDirectional Laser Probe Recalled for Fiber Extension and Direction Difficulties
FDA (Devices) · 2024-03-27
Same hazard · component loosening
See all →- HighFresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor
FDA (Devices) · 2024-05-29
- HighMicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
FDA (Devices) · 2016-09-14
- SevereMicroPort Advance II Tibial Base Recalled for Component Loosening
FDA (Devices) · 2016-09-14
- SevereMicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
FDA (Devices) · 2016-09-14
- SevereMicroPort Recalls Advance II Modular Tibial Base Components
FDA (Devices) · 2016-09-14