Flexible Uretero-Renoscopes Recalled for Inadequate Disinfection
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.
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 an FDA Class II recall with no reported illnesses or hospitalizations. However, it involves a risk-of-harm medical device with a documented manufacturing defect in the disinfection process, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of the Flexible Video-Uretero-Renoscope (FLEX-XC), a surgical instrument used in urological procedures. All units with serial numbers manufactured or distributed since January 2018 are included. The devices were distributed throughout the United States and to Mexico, Lebanon, and South Korea.
The FDA has classified this as a Class II recall. The disinfection process used for these instruments fails to achieve the expected six-log reduction in microorganisms. A six-log reduction means eliminating 99.9999% of microorganisms; failure to achieve this level means adequate disinfection cannot be assured, and bacteria and other microorganisms may remain on the instrument surfaces.
Affected units include multiple SKU variations: 11278VSA, 11278VSAK, 11278VSE, 11278VSEK, 11278VSU, 11278VSUK, 11278VSUA, 11278VSUAK, 11278VSUE, and 11278VSUEK. These were manufactured under product codes Z23117US-BA (released October 2020) and Z18447US-BC (released March 2018).
Since these instruments must be properly disinfected between uses in patient care, the failure of the disinfection process to achieve adequate microbial reduction presents a potential infection risk for patients undergoing urological procedures.
The recalled product
- Product
- 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
- 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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