Z-1076-2018Class II

GENICON EZEE Retrieval, sterile, Rx only

Name: Z-1076-2018 GENICON EZEE Retrieval, sterile, Rx only
Creator: Genicon, Inc.
Published: 2017-07-19
License: https://open.fda.gov/license/

Genicon, Inc. / initiated 2017-07-19 / Terminated / root cause: design

FDA source

Genicon, Inc. began a recall of GENICON EZEE Retrieval, sterile, Rx only on 2017-07-19. FDA classified it as Class II and gives the reason as "Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1076-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-19
Posted: 2018-03-16
Terminated: 2020-05-18
Recalling firm: Genicon, Inc.
Product: GENICON EZEE Retrieval, sterile, Rx only.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified via email on 07/19/2017. Instructions included
Quantity in commerce: 2,967 units
Distribution: Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
Product codes and lots: Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1076-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-16

Product code GCJ

K162059Class IIEzee RetrievalGenicon, Inc. / cleared 2016-09-29

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)