Envoy Medical Recalls
2 recalls on record · February 6, 2013 to August 8, 2018 · Medical Devices
Recalls by year
13
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 8, 2018Medical DevicesFDA
Envoy Medical Corporation recalls Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018).
Hazard: 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.
February 6, 2013Medical DevicesFDA
Envoy Medical Corporation recalls Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System.
Hazard: 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.