Flexible video uretero-renoscopes recalled for inadequate sterilization
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination 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: FDA Class II recall for inadequate sterilization of surgical instruments. The failure to achieve expected microbial reduction creates a theoretical risk of contamination. No illnesses or injuries have 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. The affected models include 11278VSA, 11278VSAK, 11278VSE, 11278VSEK, 11278VSU, 11278VSUK, 11278VSUA, 11278VSUAK, 11278VSUE, and 11278VSUEK. All serial numbers manufactured or distributed since January 2018 are affected.
The recall was issued because these instruments may fail to achieve the expected six-log reduction in microorganisms following the disinfection process. This means microorganisms could remain on the scope after disinfection, potentially creating an infection risk.
The recalled scopes have been distributed throughout the United States (including all states) and internationally to Mexico, Lebanon, and South Korea.
Affected healthcare facilities and users should verify whether they have these instruments and contact Karl Storz Endoscopy or the FDA with any questions or concerns about the recalled devices.
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…
- 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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