FDA Medical Device Recalls (openFDA)
Genicon, Inc.: GENICON EZEE Retrieval, sterile, Rx only.
- Recall number
- Z-1076-2018
- Recalling firm
- Genicon, Inc.
- Product
- GENICON EZEE Retrieval, sterile, Rx only.
- Status
- Terminated
- Initiated
- 2017-07-19
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
- Root cause
- Device Design
- Action
- Consignees were notified via email on 07/19/2017. Instructions included
- Quantity
- 2,967 units
- Distribution
- Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
- Lot, serial or model codes
- Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.
- 510(k) numbers
- ["K162059"]
- 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