Recall Z-2323-2026
- Recall number
- Z-2323-2026
- Event number
- 98814
- Firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands
- Firm FEI
- 3002806863
- Product code
- HQE
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-05
- Root cause
- Process design
- 510(k) numbers
- K213467, K830216, K891601, K946135, K980488, K910973, K934600, K921460, K853430, K832235, K834160, K884043, K870775, K915745, K832703, K883975, K860891, K980400, K860014, K953575, K884557, K801850, K010082, K862943, K912384, K851936, K884556, K862188, K842197, K102222
Product#
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Reason for Recall#
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.