GENICON EZEE Retrieval, sterile, Rx only recallZ-1076-2018 · Genicon, Inc. · initiated Jul 19, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Genicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

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

FDA root cause category: Device Design

Consignees were notified via email on 07/19/2017. Instructions included

Recall number: Z-1076-2018
Status: Terminated
Initiated by the company: Jul 19, 2017
Recalling firm: Genicon, Inc.
Quantity: 2,967 units
Product code: GCJ
FDA submissions: K162059
Distribution: Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

GENICON EZEE Retrieval, sterile, Rx only.

Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.

1 device in the FDA device registry whose identifier appears in the recall's code information.

EZee Retrieval 550-000-000
Genicon, Inc. · Laparoscope, General & Plastic Surgery
1 recall1 report

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.