Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OtoLase Starter Kit Recalled by LUMENIS, LTD. Due to The potential for unsterilized product within finished product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LUMENIS, LTD. directly.
Affected Products
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Quantity: 13 units
Why Was This Recalled?
The potential for unsterilized product within finished product labeled as sterile.
Where Was This Sold?
This product was distributed to 2 states: PA, WI
About LUMENIS, LTD.
LUMENIS, LTD. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report