FDA Medical devices recall ·
OtoLase Starter Kit recall
- Recall number
- Z-2344-2025
- Date
- (initiated July 22, 2025)
- Company / brand
- Lumenis, Ltd.
Yokneam Ind. Park, Yokne'Am Ilit, N/A, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Why was it recalled?
The potential for unsterilized product within finished product labeled as sterile.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
Distribution
Domestic: PA, WI; International: Germany, India;
States: Pennsylvania Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2344-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.