Saint Paul, MN, United States
Envoy Medical Corporation recalls
1 recall recorded since 2018, most recently on 28 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 June 2018
- Terminated
- 3 November 2020
- 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.
- Distribution
- US Distribution to states of: FL, OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2590-2018
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.