OtoLase Starter Kit — Class II medical device recall Z-2344-2025
Ongoing recall by LUMENIS, LTD., reported 2025-08-27, distributed in PA, WI. The potential for unsterilized product within finished product labeled as sterile.
| Recall number | Z-2344-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUMENIS, LTD., Yokne'Am Ilit, N/A, Israel |
| Recall initiated | 2025-07-22 |
| Classified | 2025-08-21 |
| Reported by FDA | 2025-08-27 |
| Distributed | PA, WI |
| Countries outside the US | DE, IN |
| Quantity | 13 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 07290109142807 |
| Lot numbers | 32644549, 32769567 |
| Expiration dates | 2025-08-22 |
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 for recall
The potential for unsterilized product within finished product labeled as sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2344-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.