Lumenis recalls OtoLase Starter Kit (UPN AC-2003748) due to potential unsterilized product in items labeled as sterile. Affected units include specific batch numbers and expiration dates.
The potential for unsterilized product within finished product labeled as sterile.
Lumenis is recalling its OtoLase Starter Kit because some units may contain unsterilized components despite being labeled sterile. This could lead to infection risks during medical procedures if used without proper sterilization.
The product may contain unsterilized components even though it's labeled as sterile. This could lead to infections during medical procedures if the kit isn't properly sterilized before use.
Medical professionals using the OtoLase Starter Kit for surgical procedures are most at risk. Patients undergoing surgery with this kit could face infection if the product isn't properly sterilized.
Check for the product name 'OtoLase Starter Kit' with UPN AC-2003748. Affected units have batch numbers 32644549 or 32769567 and expire by August 22, 2025.
Verify the batch number and expiration date on the product label to confirm if it's affected.
The recall indicates a potential risk of unsterilized components, so it's not safe to use without confirming it's not affected.
The recall doesn't specify a remedy, so check the product details to see if it's affected before deciding on next steps.
Look for batch numbers 32644549 or 32769567 with an expiration date of August 22, 2025.
We’ve drafted a message you can send Lumenis to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2025 — Lumenis Lumenis Hello, I own a Lumenis that is covered by recall Z-2344-2025 from Lumenis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
