OtoLase starter kits recalled over potentially unsterilized product labeled as sterile
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; product labeled sterile that may not be sterile is a potential harm in surgery and no injuries are reported.
Plain-English summary
The OtoLase Starter Kit, UPN AC-2003748, UDI-DI 07290109142807, is being recalled. The product is indicated for a variety of surgical uses including ablation, coagulation, incision, excision and vaporization of soft tissue. The affected batches are 32644549 and 32769567, with an expiration date of 22Aug2025. The recall covers 13 units distributed in Pennsylvania and Wisconsin and internationally in Germany and India.
The recall was issued because of the potential for unsterilized product within finished product labeled as sterile. The FDA classified the action as Class II.
Hospitals and surgical centres holding these batches should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Manufacturer
- LUMENIS, LTD.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UPN: AC-2003748
- UDI-DI: 07290109142807
- Batch Numbers: 32644549 and 32769567
- Expiration Date: 22Aug2025
Distribution
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