CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
OtoLase Starter Kit recalled by Lumenis
Lumenis is recalling OtoLase Starter Kit, distributed in Pennsylvania, Wisconsin. The recall was initiated on 22 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2344-2025
- FDA event ID
- 97279
- Recalling firm
- Lumenis, Yokne'Am Ilit, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2025
- FDA classified
- 21 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 22 Jul 2025 | Recall initiated by company | |
| 21 Aug 2025 | Classified by FDA | +30 days |
| 27 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for unsterilized product within finished product labeled as sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Where it was distributed
Domestic: PA, WI; International: Germany, India;
Questions about this recall
Why was it recalled?
The potential for unsterilized product within finished product labeled as sterile.
Which lots are affected?
UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
Where was it sold?
Domestic: PA, WI; International: Germany, India;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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