Reported May 18, 2022 · Ongoing
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS…
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?
- 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
- Lot codes and dates
- 11272V N/A Flexible CMOS Video Cysto Urethroscope
- Z18446US-BE (01/2020) UDI Code4048551313350; 11272VA 11272VAK Flexible CMOS Video Cysto Urethroscope
- Z18446US-BE (01/2020) UDI Code4048551402481; 11272VU 11272VUK Flexible CMOS Video Cysto Urethroscope
- Z18446US-BE (01/2020) UDI Code4048551313367; 11272VUA 11272VUAK Flexible CMOS Video Cysto Urethroscope
- Z18446US-BE (01/2020) UDI Code4048551402559; 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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