Karl Storz cystoscopes recalled due to inadequate disinfection
Karl Storz cystoscopes manufactured since January 2018 are recalled because they may not achieve required disinfection levels. Inadequate disinfection could lead to patient infection during urological procedures.
What this means for you
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: FDA Class II recall of a surgical instrument with critical sterilization requirements. The hazard—failure to achieve required disinfection levels—represents a risk-of-harm product for urological procedures, meeting the criteria for High (score 3) per the rubric.
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of cystoscopes (cysto-urethro-fiberscopes) manufactured or distributed since January 2018. These instruments failed to achieve the expected six-log reduction in microorganisms following the standard disinfection process.
The recalled products include Reference Numbers 11272C1, 11272C2, 11272CU1 and associated kits. All serial numbers manufactured since January 2018 are affected, distributed throughout the United States and internationally to Mexico, Lebanon, and South Korea.
Because these instruments are used in direct contact with urological tissue, inadequate disinfection represents a potential risk of patient infection during urological procedures.
Patients and healthcare providers should contact Karl Storz Endoscopy for guidance. Healthcare facilities are advised to review their inventory and consult manufacturer instructions regarding these recalled instruments.
The recalled product
- Product
- CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- inadequate-disinfection
- infection-risk
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 (1)
- All Serial Numbers manufactured/distributed since January 2018.
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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