Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Esteem Programmer Model 6001 Recalled by Envoy Medical Corporation Due to Envoy Medical is conducting a voluntary correction of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Envoy Medical Corporation directly.
Affected Products
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.
Quantity: 44
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 14 states: AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, TX
About Envoy Medical Corporation
Envoy Medical Corporation has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report