Esteem Programmer Model 6001 — Class II medical device recall Z-0750-2013
Terminated recall by Envoy Medical Corporation, reported 2013-02-06, distributed in AL, AZ, CA, CT, FL, GA, IL, MA…. Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Este
| Recall number | Z-0750-2013 |
|---|---|
| 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 | 2013-01-09 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-04-09 |
| Distributed | AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, TX |
| Countries outside the US | DE |
| Quantity | 44 |
| Lot numbers | EMC0003827, EMC0003852, EMC0003935, EMC0003968, EMC0003985, EMC0004011, EMC0004027, EMC0004028, EMC0004053, EMC0004114, EMC0004125, EMC0004126, EMC0004191, EMC0004196, EMC0004233, EMC0004234, EMC0004235, EMC0004286, EMC0004303, EMC0004304, EMC0004310, EMC0004356, EMC0004376, EMC0004399, EMC0004491, EMC0004510, EMC0004594, EMC0004639, EMC0004665, EMC0004724, EMC0004757, EMC0004759, EMC0004797, EMC0004844, EMC0004922, EMC0004923, EMC0004928, EMC0004929, EMC0004930, EMC0004932 and 4 more |
| Model numbers | 3001, 6001 |
Product
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
Reason for recall
Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
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-0750-2013. 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.