FDAHealthJuly 22, 2025
LUMENIS, LTD. — OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
⚠️ The potential for unsterilized product within finished product labeled as sterile.
Is this relevant to me?
- Geography
- PA, WI
- Source agency
- FDA
- Category
- Health
- Published
- July 22, 2025
Domestic: PA, WI; International: Germany, India;
What's affected?
- Product
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Brand
- LUMENIS, LTD.
- Lot code
- UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
Additional details
UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.