Cysto-Urethroscope Disinfection Process Failure Affects Serial Numbers Since 2018
Karl Storz Endoscopy is recalling Flexible Video Cysto-Urethroscopes due to a disinfection process failure that may not adequately eliminate microorganisms. Affected units have been distributed nationwide and internationally since January 2018.
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: This is a Class II FDA recall of a reusable medical device with failure in a critical disinfection control point. While no illnesses or injuries have been reported, the potential risk of microorganism transmission during invasive urological procedures justifies a High severity rating.
Plain-English summary
Karl Storz Endoscopy is recalling all units of the 11272VUE and 11272VUE-R Flexible Video Cysto-Urethroscope manufactured or distributed since January 2018. These devices are reusable endoscopes used for urological diagnostic and therapeutic procedures.
The recall was initiated because the disinfection process for these devices fails to achieve the expected six-log reduction in microorganisms. This failure means the devices may not be adequately disinfected between uses, potentially allowing microorganisms to persist on the device surface.
The affected units have been distributed throughout the United States, including all territories, as well as Mexico, Lebanon, and South Korea. Healthcare facilities using these devices should verify their serial numbers against the official recall notice.
Facilities should cease use of affected units immediately and contact Karl Storz Endoscopy or the FDA for further instructions. No illnesses or injuries associated with this recall have been reported as of the announcement date.
The recalled product
- Product
- 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscope
- Hazard
- microorganism-contamination
- disinfection-failure
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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