Karl Storz Endoscopy 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); Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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);
Brand
Karl Storz Endoscopy
Lot Codes / Batch Numbers
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) UDI Code: 4048551276884, All Serial Numbers manufactured/distributed since January 2018.
Products Sold
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.
Karl Storz Endoscopy is recalling 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero due to Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Recommended Action
Per FDA guidance
On 04/01 and 6/2022, the firm emailed an "Urgent Medical Device Recall" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing. Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed. Testing showed that required efficacy level of disinfection using CIDEX OPA was not achieved. To the extent included in the current applicable instructions for use, the following methods are being removed as reprocessing methods from the instructions for use of the affected endoscopes. +Manual High-Level Disinfection: -Cidex-OPA -Revital-Ox" RESERT (e.g., 2.0% Accelerated Hydrogen Peroxide solution). +Automated Endoscope Reprocessor: -Medivators AER -Reliance EPS -EvoTech ECR Customer Actions: 1. Immediately discontinue use of all high-level disinfection methods for reprocessing affected endoscopes. 2. The affected endoscopes should be sterilized after each use by one of the sterilization methods recommended in the instructions for use specific to each endoscope. 3. If your facility does not have access to a sterilization method recommended in the applicable instructions for use, immediately discontinue use of the affected endoscopes and return products to KARL STORZ. 4. Ensure all relevant personnel in your organization are aware of recall. 5. Updated instructions for use will be available at https://spwebspace.karlstorz.com/sites/HLDCorrection/SitePages/Home.aspx . Once the updated instructions for use are available, discard any prior versions of the instructions for use. Questions: Telephone: 1-888-352-9616 Fax: 1-888-912-7088 E-Mail: karlstorz7041@sedgwick.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026