FDA Device recall Z-2005-2020
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only
- FDA Device
- Class II
- ongoing
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only by Genicon, citing genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2005-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-06-27 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Genicon |
| Distribution | US |
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.
Reason
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Identifiers
| code_info | Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2005-2020%22
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