Z-2005-2020Class II

Genicon EZee Single Use Specimen Retrieval Bag -

Name: Z-2005-2020 Genicon EZee Single Use Specimen Retrieval Bag -
Creator: Genicon, Inc.
Published: 2018-06-27
License: https://open.fda.gov/license/

Genicon, Inc. / initiated 2018-06-27 / Open, Classified / root cause: labeling and UDI

FDA source

Genicon, Inc. began a recall of Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be... on 2018-06-27. FDA classified it as Class II and gives the reason as "Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2005-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-06-27
Posted: 2020-05-14
Recalling firm: Genicon, Inc.
Product: Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall notification letter and updated Instructions for Use (IFU) labeling was sent to consignees on 5/1/2020. The firm is asking that labeling be provided to surgeons for them to read and to familiarize themselves with proper use of the specimen bag for multiple retrievals in the same patient. An Acknowlegement/Receipt Form was provided with response required.
Quantity in commerce: 1550
Distribution: Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
Product codes and lots: Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2005-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2005-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-20	2020-05-14

Product code GCJ

K180579Class IIEzee RetrievalGenicon, Inc. / cleared 2018-03-19

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)