Recall archive / FDA device enforcement
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis... — FDA record Z-2344-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 22, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Reason
- The potential for unsterilized product within finished product labeled as sterile.
- Classification
- Class II
- Recalling firm
- LUMENIS, LTD.
- Quantity
- 13 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2344-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: PA, WI; International: Germany, India;
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 27, 2025
- Recall initiation date
- Jul 22, 2025
- Center classification date
- Aug 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.