Genicon EZee Single Use Specimen Retrieval Bag — Class II medical device recall Z-2005-2020
Ongoing recall by Genicon, Inc., reported 2020-05-20, distributed nationwide. Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple sp
| Recall number | Z-2005-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genicon, Inc., Winter Park, FL, United States |
| Recall initiated | 2018-06-27 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK |
| Quantity | 1,550 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00877972005230 |
| Lot numbers | I8920 |
| Model numbers | 550-000-000 |
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 for recall
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2005-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.