Z-2344-2025 Class II Ongoing
FDA device recall Z-2344-2025 was initiated by LUMENIS, LTD. on July 22, 2025 and is designated Class II. Reason for recall: The potential for unsterilized product within finished product labeled as sterile. The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2025
- Initiation Date
- July 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Reason for Recall
The potential for unsterilized product within finished product labeled as sterile.
Distribution Pattern
Domestic: PA, WI; International: Germany, India;
Code Information
UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;