Karl Storz Video Ureteroscopes May Not Be Properly Sterilized
Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.
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 medical device recall for sterilization process failure with potential infection risk. No illnesses or injuries are reported in the source material, but the risk-of-harm nature of improper sterilization of instruments used internally in patients warrants a High severity rating.
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of video ureteroscopes and flexible video ureteroscopes used in endoscopic urinary tract procedures. The recall affects all serial numbers manufactured or distributed since January 2018.
The recalled devices may fail to achieve the expected six-log reduction (99.9999% elimination) in microorganisms during the standard disinfection process. This could result in microorganisms remaining on the device surface, creating a potential infection risk when the instrument is reused on patients.
The recalled devices were distributed to healthcare facilities throughout the United States (all states, District of Columbia, and Guam), as well as Mexico, Lebanon, and South Korea.
Healthcare facilities should consult Karl Storz Endoscopy and the FDA regarding management of affected devices. Patients who have been treated with these devices should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible…
- 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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