Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm) 7225.ALCRecalls & 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. Jan 15, 2024Class IIOpen, Classified

   When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

   Z-1332-2024 · Root cause: Process control · 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-2323-2026 · Apr 30, 2026 · Open, Classified
  TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
• 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)