Data Foundry

Medical device recalls 2019

FLEXIBLE NEURO-FIBERSCOPE — Class II medical device recall Z-2425-2019

Terminated recall by Karl Storz Endoscopy, reported 2019-09-04, distributed in AL, CA, FL, MA, MI, MO, NC, NH…. The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Recall numberZ-2425-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmKarl Storz Endoscopy, El Segundo, CA, United States
Recall initiated2019-02-20
Classified2019-08-28
Reported by FDA2019-09-04
Terminated2020-07-07
DistributedAL, CA, FL, MA, MI, MO, NC, NH, OH, OR, PA, VA, WA
Quantity22 scopes
Serial numbers2039298, 2062041, 2161516, 2172240, 2178784, 2183837, 2188370, 2194154, 2198276, 2198341, 2204079, 2210200, 2220959, 2244117, 2247464, 2248783
Model numbers11282BN1

Product

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

Reason for recall

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

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-2425-2019. 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.