Z-1061-2022Class II

CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2...

Name: Z-1061-2022 CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2...
Creator: Karl Storz Endoscopy
Published: 2022-04-01
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2022-04-01 / Open, Classified

FDA source

Karl Storz Endoscopy began a recall of CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number... on 2022-04-01. FDA classified it as Class II and gives the reason as "Failure to achieve the expected six-log reduction in microorganisms following the disinfection process". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1061-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-01
Posted: 2022-05-12
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: 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
Product code: FBO Cystourethroscope
Reason for recall: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
FDA root cause: Under Investigation by firm
Action: 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: [email protected]
Quantity in commerce: All Serial Numbers manufactured/distributed since January 2018
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1061-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1062-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1063-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1064-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1065-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1066-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1067-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1068-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1069-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1070-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12

Product code FBO

K945185Class IICystoscope (78Faj)endoscope,fiberoptic (78Gdb)KARL STORZ Endoscopy-America, Inc. / cleared 1995-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)