Z-1531-2020Class II

Karl Storz, Model # 11161C2, Flexible Neuroscope

Name: Z-1531-2020 Karl Storz, Model # 11161C2, Flexible Neuroscope
Creator: Karl Storz Endoscopy
Published: 2019-08-27
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2019-08-27 / Open, Classified / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy began a recall of Karl Storz, Model # 11161C2, Flexible Neuroscope on 2019-08-27. FDA classified it as Class II and gives the reason as "During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1531-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-27
Posted: 2020-03-20
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Karl Storz, Model # 11161C2, Flexible Neuroscope
Product code: GWG Endoscope, Neurological
Reason for recall: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 8/27/2019 the firm sent an "Urgent Medical Device - Correction" letter detailing the recall was mailed to consignees. In addition to addressing the recall it asked customers to do the following: 1. If you use STERIS SS1E to sterilize the above scopes, and if you selected the specific QCK and tray according to the KARL STORZ Instruction Manuals, please be aware that the sterility of the scope cannot be guaranteed and that you should consider taking necessary actions to address any patient safety concerns. 2. Other than STERIS SS1E system, these scopes can also be sterilized via EtO, STERRAD Systems (NX, 100S and 100NX), V. PRO maX and V. PRO 60. If you use any of these sterilization methods, the QCK error should have no safety impact to your patients. 3. If you have experienced any adverse event with the above scopes, please let us know and at the same time, follow the FDAs MedWatch Adverse Event Reporting process at: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#voluntary 4. Attached with this letter we are providing you a copy of the newly revised Instruction Manual for the scope(s) you have received. They are: -11005BC1 Flexible Bronchoscope Print Control #Z21493US-BA -11161C2 Flexible Neuroscope Print Control #Z21491US-BA -11282BN1 Flexible Pediatric Neuroscope Print Control #Z21491US-BA 5. Please be sure to use only the above listed manuals and discard all others. If you would like to receive additional copies, please contact our Technical Support at 800-421-0837, Ext. 5350. If you have any patient safety questions please do not hesitate to contact our Chief Medical Officer, Dr. Dennis Fowler, at 424-218-8603.
Quantity in commerce: 42 scopes
Distribution: US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1531-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1530-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1531-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1532-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code GWG

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)