Karl Storz Flexible Ureteroscopes Risk Microbial Contamination After Disinfection
Karl Storz recalls specific flexible ureteroscope models from 2016-2018 due to failure to reduce microorganisms during disinfection, posing infection risks during medical procedures.
Lower-risk recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Contact the company
What happened, in plain English
Karl Storz is recalling certain flexible ureteroscopes that may not properly reduce microorganisms after disinfection. This could lead to infections during medical procedures if the instruments are reused without adequate cleaning. Read more at govinfonow.com/recall/60844-karl-storz-flexible-ureteroscopes-risk-microbial-contamination-after-disinfection.
Source Summary by GovInfoNow · govinfonow.com/recall/60844-karl-storz-flexible-ureteroscopes-risk-microbial-contamination-after-disinfection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1067-2022
Cite this page
“Karl Storz Flexible Ureteroscopes Risk Microbial Contamination After Disinfection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60844-karl-storz-flexible-ureteroscopes-risk-microbial-contamination-after-disinfection. Based on FDA recall #Z-1067-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1067-2022%22&limit=1).
Why it’s dangerous
The ureteroscopes may not achieve the required six-log reduction in microorganisms after disinfection. This means harmful bacteria could survive and potentially cause infections during medical procedures if the instruments are reused without proper cleaning.
Who’s affected
Healthcare professionals using the recalled ureteroscopes for medical procedures are most at risk. Patients undergoing procedures with these instruments could face infection risks.
How to tell if you have this one
Check for model numbers: 11278A2, 11278AC1, 11278AC2, 11278ACU1, or 11278AU1. These were manufactured from January 2018 onward. The UDI codes listed in the recall notice also identify affected units.
- Brand
Karl Storz- Category
Medical device
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1061-2022 | 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; 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 Code: 4048551226162; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018 |
| Z-1062-2022 | 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; 11272V N/A Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313350; 11272VA 11272VAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402481; 11272VU 11272VUK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313367; 11272VUA 11272VUAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402559; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018 |
| Z-1063-2022 | 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021); 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) UDI Code: 4048551449677; 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) UDI Code: 4048551449684; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018 |
| Z-1064-2022 | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018) UDI Code: 4048551226186; 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018) UDI Code: 4048551226193; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018 |
| Z-1065-2022 | 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551431382; 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551444351; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
| Z-1066-2022 | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018); 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551408155 All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
| Z-1067-2022 | 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);; 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
| Z-1068-2022 | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);; 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) UDI Code: 4048551276884; 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402580; 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018) UDI Code: 4048551278239; 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402634; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
| Z-1069-2022 | 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); 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402597; 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551416976; 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018) UDI Code: 4048551344385; 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402603; 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551416969; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
| Z-1070-2022 | 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); 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402597; 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551416976; 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018) UDI Code: 4048551344385; 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402603; 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551416969; All Serial Numbers manufactured/distributed since January 2018. | All Serial Numbers manufactured/distributed since January 2018. |
What to do — step by step
Check Product Model
Identify the model number on your ureteroscope to see if it matches the recalled series (11278A2, 11278AC1, etc.).
Contact Manufacturer
Reach out to Karl Storz Endoscopy directly for further guidance on the recall and potential remedies.
Where it went and when
Where it was distributed
Distributed in 50 states and D.C., and outside the U.S.
FDA distribution: “U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1067-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1067-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.