FDA Device recall Z-2344-2025
OtoLase Starter Kit
- FDA Device
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of OtoLase Starter Kit by Lumenis, citing the potential for unsterilized product within finished product labeled as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2344-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-22 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lumenis |
| Distribution | PA, WI |
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.
Identifiers
| code_info | UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2344-2025%22
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