Recall Z-2344-2025 ยท GEX Powered Laser Surgical Instrument
LUMENIS, LTD.
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
| Date | Aug 21, 2025 (initiated Jul 22, 2025) |
| Status | Open, Classified |
| Reason | The potential for unsterilized product within finished product labeled as sterile. |
| Root cause | Nonconforming Material/Component |
| Action | On July 22, 2025, URGENT MEDICAL DEVICE REMOVAL - IMMEDIATE ACTION REQUIRED letters were sent to customers. Instructions: " Immediately discontinue use and segregate the affected products to prevent accidental use and follow provided removal instructions on the attachment. " Post this information in a visible location near where the affected products are stored to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any healthcare professional within your organization and with any organization where the affected products may have been |
| Quantity | 13 units |
| Distribution | Domestic: PA, WI; International: Germany, India; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130164 | FIBERLASE ENDURE CO2 FIBER Lumenis, Ltd., Mar 24, 2013 |