Flexible Cystoscopes Recalled for Inadequate Disinfection Process
Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially 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: This is an FDA Class II recall involving inadequate disinfection of reusable endoscopic instruments. Although no illnesses or injuries have been reported in the source text, the hazard involves potential microbial cross-contamination. Per the rubric, when illness/injury is not reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Karl Storz Flexible Cystoscope model 11274BCU1/11274BCUK1 (Z18449US-BD) is subject to recall by the FDA due to a failure in the disinfection process. These reusable endoscopic instruments are used in urological procedures.
The disinfection process for affected units has failed to achieve the expected six-log reduction in microorganisms, which is the standard required to safely reuse these instruments. Devices affected include all serial numbers manufactured and distributed since January 2018.
The recalled instruments were distributed to healthcare facilities throughout the United States, Mexico, Lebanon, and South Korea. The FDA has classified this as a Class II recall.
Healthcare facilities using these instruments should contact Karl Storz Endoscopy for further instructions and guidance regarding appropriate follow-up actions.
The recalled product
- Product
- 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscope
- Affected units
- 2,018
Distribution
Part of a larger recall action
This product is one of 10 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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