CMOS Video Cysto-Urethroscope Disinfection Failure Puts Patients at Infection Risk
Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.
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: The device fails to meet disinfection standards, creating a risk-of-harm situation. No reported illnesses, injuries, or hospitalizations are documented in the source, and the hazard is theoretical, placing this Class II recall in the high-risk category where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices (models 11272V, 11272VA, 11272VAK, 11272VU, 11272VUK, 11272VUA, and 11272VUAK). The recalled units fail to achieve the expected six-log reduction in microorganisms during the disinfection process. This deficiency in microbial disinfection creates a risk of pathogen transmission between patients.
All units manufactured or distributed since January 2018 are affected by this recall. The devices have been distributed throughout the United States (all 50 states plus Washington DC and Guam) and internationally to Mexico, Lebanon, and South Korea.
The recalled product
- Product
- 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 2,018
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
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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