Z-2425-2019Class II

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Name: Z-2425-2019 FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Creator: Karl Storz Endoscopy
Published: 2019-02-20
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2019-02-20 / Terminated / root cause: manufacturing process

FDA source

Karl Storz Endoscopy began a recall of FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 on 2019-02-20. FDA classified it as Class II and gives the reason as "The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2425-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-20
Posted: 2019-08-28
Terminated: 2020-07-07
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Product code: GWG Endoscope, Neurological
Reason for recall: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A safety alert was sent to all affected consignees on 7/26/209 via FED Ex. The safety alert informed consignees of the following: 1. From the reprocessing point of view, depending on the methods of reprocessing at your facility, the scope built with the incorrect port may impact the reprocessing outcome. 2. When using STERIS System for sterilization, the above QKC connectors connect onto one port, and leaving the other QKC connector open. The STERIS system, however, will complete the cycle without any indication of a problem, yet the sterility of the scope cannot be guaranteed. If you use STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 3. Please complete the attached Immediate Action Requested form and follow the instructions outlined on the form. If you have experienced any adverse event with the scope, please let us know and at the same time following the FDAs MedWatch Adverse Event Reporting process, https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#voluntary. 4.If your scope is CORRECT, no other actions needed. If your scope is INCORRECT, our Customer Support will contact you and provide you an RMA number to return your scope to us, and at the same time arrange a no charge replacement sent to you via overnight delivery. 5. If you have any questions please contact the following person: Reprocessing Shaun McGinley, Director of Reprocessing 424-218-8247 Patient Safety Dr. Dennis Fowler, Chief Medical Officer 424-218-8603
Quantity in commerce: 22 scopes
Distribution: US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
Product codes and lots: SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2425-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2425-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-28

Product code GWG

K002788Class IIKsea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. / cleared 2000-10-23

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)