Final Pack — Class II medical device recall Z-2590-2018
Terminated recall by Envoy Medical Corporation, reported 2018-08-08, distributed in FL, OR. Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pa
| Recall number | Z-2590-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Envoy Medical Corporation, Saint Paul, MN, United States |
| Recall initiated | 2018-06-28 |
| Classified | 2018-08-01 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2020-11-03 |
| Distributed | FL, OR |
| Quantity | 4 units |
| Reason classes | labeling, sterility |
| Lot numbers | EMC0006145, EMC0006155, EMC0006217 |
| Model numbers | 2001 |
Product
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Reason for recall
Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
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-2590-2018. 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.