Reported Aug 27, 2025 · Ongoing
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation,…
Lumenis, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LUMENIS, LTD. · Yokneam Ind. Park · Yokne'Am Ilit, N/A · N/A
Is this the product you have?
- OtoLase Starter Kit
- UPNAC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue
- Lot codes and dates
- UPNAC-2003748
- UDI-DI07290109142807
- Batch Numbers32644549 and 32769567
- Expiration Date22Aug2025
- Amount recalled
- 13 units
Where it was sold
Why it was recalled
The potential for unsterilized product within finished product labeled as sterile.
This product could cause temporary or reversible health problems — stop using it.
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