Data Foundry

Medical device recalls 2022

11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS… — Class II medical device recall Z-1062-2022

Ongoing recall by Karl Storz Endoscopy, reported 2022-05-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Recall numberZ-1062-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmKarl Storz Endoscopy, El Segundo, CA, United States
Recall initiated2022-04-01
Classified2022-05-12
Reported by FDA2022-05-18
DistributedAK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, WY
Countries outside the USKR, LB, MX
Quantity2,018
UPC / GTIN / UDI-DI04048551313350, 04048551313367, 04048551402481, 04048551402559

Product

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

Reason for recall

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1062-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.