Reported May 18, 2022 · Ongoing

CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2…

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?

  • CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Lot codes and dates
  • 11272C1 n/a Flexible Cysto-Urethroscope Fiberscope
  • Z18449US-BD (08-2018) UDI Code
    • 4048551226100
    • 11272C2 11272CK2 Flexible Cystoscope
  • Z18449US-BD (08-2018) UDI Code
    • 4048551226100
    • 11272CU1 11272CUK1 Flexible Cystoscope
  • Z18449US-BD (08-2018) UDI Code4048551226162; 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.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.