Karl Storz Laser Surgical Instruments Recalled Due to Sterilization Concerns
Karl Storz laser surgical instruments lack validated sterilization procedures, creating infection risk after reprocessing. The FDA has recalled 85 units distributed nationwide and in Argentina.
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: No reported illnesses or deaths. This is a risk-of-harm medical device where inadequate sterilization could cause infection, but no injuries have been reported. Classified as High per the rubric for risk-of-harm products without reported illness.
Plain-English summary
Karl Storz Endoscopy has recalled LASER Application Instruments (REF: 8694 and 461000), which are surgical devices used in medical procedures. Eighty-five units were distributed nationwide across multiple U.S. states and in Argentina.
The instruments lack evidence of a validated reprocessing method, meaning there is no assured way to sterilize them properly after use. This creates a risk of infection when the instruments are reused in subsequent procedures, as they do not maintain sterility assurance after reprocessing.
Healthcare facilities and surgical centers that have received these instruments should stop using them until appropriate sterilization procedures can be validated. Patients who may have undergone procedures using these reprocessed instruments should consult with their healthcare provider if they develop signs of infection.
The FDA has classified this as a Class II recall. Healthcare providers with these instruments should contact Karl Storz Endoscopy for further guidance on proper handling, storage, or replacement options.
The recalled product
- Product
- LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 85
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 (2)
- All lots. REF/UDI-DI: 8694/04048551216392
- 461000/04048551164860
Distribution
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