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Flex-X 11278VSUERecalls & reported problems

Karl Storz GmbH & Co. KG · Video Uretero-Renoscope FLEX-X C · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 1, 2022Open, Classified

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

    Z-1070-2022 · Root cause: Under Investigation by firm · FDA record ↗

  2. Apr 1, 2022Open, Classified

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

    Z-1069-2022 · Root cause: Under Investigation by firm · FDA record ↗

Other Ureteroscope and accessories, flexible/rigid devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page