Genicon, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2005-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 27, 2018

Date Posted: May 20, 2020

Recall Number: Z-2005-2020

Event ID: 85403

Reason for Recall:

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

Status: Ongoing

Product Quantity: 1550

Code Information:

Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.

Voluntary or Mandated:

Voluntary: Firm initiated