Genicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1076-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

GENICON EZEE Retrieval, sterile, Rx only.

Product Classification:

Class II

Date Initiated: July 19, 2017

Date Posted: March 28, 2018

Recall Number: Z-1076-2018

Event ID: 78655

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,967 units

Code Information:

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

Distribution Pattern:

Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated