FDA Device recall Z-2590-2018
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018)
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018) by Envoy Medical, citing 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 prio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2590-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-28 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Envoy Medical |
| Distribution | FL, OR |
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
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.
Identifiers
| code_info | Lot Numbers: EMC0006145, EMC0006155, & EMC0006217 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2018%22
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