Class II — Envoy Medical Corporation
| Recalling firm | ENVOY MEDICAL CORPORATION |
|---|---|
| Registered facility | ENVOY MEDICAL CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 4 Units |
| Distribution | US Distribution to states of: FL, OR |
| Initiated | 2018-06-28 |
| Classified | 2018-08-01 |
| Terminated | 2020-11-03 |
| Recall number | Z-2590-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Envoy Medical Corporation (Z-2590-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80489/
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