FDA Medical Device Recalls (openFDA)
Genicon, Inc.: 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.
- Recall number
- Z-2005-2020
- 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.
- Status
- Open, Classified
- Initiated
- 2018-06-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
- 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
- 1550
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
- Lot, serial or model codes
- Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
- 510(k) numbers
- ["K180579"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002590791
- Firm city
- Winter Park
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28