Lumenis, Ltd. is recalling 13 units of the OtoLase Starter Kit because products labeled as sterile may not be sterilized. These kits are used in surgical procedures for cutting, vaporizing, and coagulating soft tissue. The affected kits are identified by batch numbers 32644549 and 32769567 with an expiration date of August 22, 2025.
Using unsterilized equipment during surgery poses a risk of infection or other complications to the patient. No injuries or incidents have been reported in the provided data.
Indicated for surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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