Data Foundry

Medical device recalls 2018

GENICON EZEE Retrieval — Class II medical device recall Z-1076-2018

Terminated recall by Genicon, Inc., reported 2018-03-28, distributed in FL, IL, MI, TN, UT. Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

Recall numberZ-1076-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGenicon, Inc., Winter Park, FL, United States
Recall initiated2017-07-19
Classified2018-03-16
Reported by FDA2018-03-28
Terminated2020-05-18
DistributedFL, IL, MI, TN, UT
Countries outside the USCH, DK, DO, ES, GB, IE
Quantity2,967 units
UPC / GTIN / UDI-DI00877972005223
Lot numbersI8095, I8162
Model numbers550-000-000

Product

GENICON EZEE Retrieval, sterile, Rx only.

Reason for recall

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

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-1076-2018. 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.