OtoLase Starter Kit recall
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization…
Why was OtoLase Starter Kit recalled?
The potential for unsterilized product within finished product labeled as sterile.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
- Product
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization…
- Recalling firm
- LUMENIS, LTD.
- Quantity
- 13 units
- Distribution
- Domestic: PA, WI; International: Germany, India;
- Recall date
- August 27, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)