Envoy Medical Corporation
FDA Regulatory Profile
Envoy Medical Corporation has 2 FDA recalls, 8 inspections, 1 510(k) clearance and 1 compliance action on record.
- Latest recall
- Z-2590-2018 · Class II · Jun 28, 2018
- Latest inspection
- Jul 2, 2025 · OAI
- Latest 510(k)
- Feb 28, 2008
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 8 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2590-2018 | Class II | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which… | Jun 28, 2018 |
| Z-0750-2013 | Class II | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally… | Jan 9, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 2, 2025 | Saint Paul, MN | Devices | Official Action Indicated (OAI) | 3004007782 |
| Feb 15, 2022 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3004007782 |
| Feb 14, 2018 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3004007782 |
| Oct 27, 2016 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3004007782 |
| Sep 4, 2014 | Saint Paul, MN | Devices | Voluntary Action Indicated (VAI) | 3004007782 |
| Mar 11, 2011 | Saint Paul, MN | Devices | Voluntary Action Indicated (VAI) | 3004007782 |
| Sep 21, 2009 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3004007782 |
| Apr 30, 2009 | Saint Paul, MN | Devices | Voluntary Action Indicated (VAI) | 3004007782 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3004007782 | Saint Paul, MN | 8 | Jul 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080032 | ENVOYCEM, MODEL 1640 | Feb 28, 2008 |