Reported May 18, 2022 · Ongoing
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible…
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- 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 Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
- Lot codes and dates
- 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC)
- Z23117US-BA (10/2020) UDI Code4048551402597; 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC)
- Z23117US-BA (10/2020) UDI Code4048551416976; 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC)
- Z18447US-BC (03/2018) UDI Code4048551344385; 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC)
- Z23117US-BA (10/2020) UDI Code4048551402603; 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC)
- Z23117US-BA (10/2020) UDI Code4048551416969; All Serial Numbers manufactured/distributed since January 2018
- Amount recalled
- All Serial Numbers manufactured/distributed since January 2018.
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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