25G Two Dimensional Cutter – 20k CPM 9268.VIT25Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K213467); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 30, 2026Class IIOpen, Classified

   An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

   Z-2323-2026 · Root cause: Process design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213467. One submission often covers many models, so check the product and lot details in each record.

• Z-2322-2026 · Apr 30, 2026 · Open, Classified
  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
• Z-2324-2026 · Apr 30, 2026 · Open, Classified
  TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
• Z-1331-2024 · Jan 15, 2024 · Open, Classified
  Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
• Z-1333-2024 · Jan 15, 2024 · Open, Classified
  Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
• Z-1332-2024 · Jan 15, 2024 · Open, Classified
  Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)