Reported May 18, 2022 · Ongoing
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);…
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?
- 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
- Lot codes and dates
- 11278A2 11278AK2 Flexible Ureteroscope
- Z20615US-BA (08-2018) UDI Code
404855140257311278AC1 N/A Flexible Ureteroscope
- Z17859US-A (04/2016) UDI Code
404855122635311278AC2 11278ACK2 Flexible Ureteroscope
- Z20615US-BA (08-2018) UDI Code
404855140250411278ACU1 11278ACUK1 Flexible Ureteroscope
- Z20615US-BA (08-2018) UDI Code
404855122637711278AU1 11278AUK1 Flexible Ureteroscope
- Z20615US-BA (08-2018) UDI Code4048551226438; 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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