OtoLase Surgical Laser Starter Kit Recalled for Potential Sterilization Failure
Lumenis recalls OtoLase Starter Kit surgical lasers due to potential sterilization failures. Units may be unsterilized despite sterile labeling, creating infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential sterilization failure. No illnesses or injuries reported; the hazard is theoretical. Per rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Lumenis, Ltd. has recalled the OtoLase Starter Kit (UPN: AC-2003748), a surgical laser device for ablation, coagulation, incision, excision, and vaporization of soft tissue. The recall affects 13 units distributed in Pennsylvania and Wisconsin domestically, and in Germany and India internationally.
The reason for the recall is the potential for unsterilized product within finished product labeled as sterile. This sterilization failure poses a risk of infection and other complications in surgical use.
The affected device has UPN AC-2003748, with Batch Numbers 32644549 and 32769567, expiration date August 22, 2025.
The recalled product
- Product
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Manufacturer
- LUMENIS, LTD.
- Category
- Medical Device — Surgical Laser
- Hazard
- unsterilized-product
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UPN: AC-2003748
- UDI-DI: 07290109142807
- Batch Numbers: 32644549 and 32769567
- Expiration Date: 22Aug2025
Distribution
Distributed in 2 states:
- PA
- WI
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