FDA Medical Device Recalls (openFDA)
Envoy Medical Corporation: 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.
- Recall number
- Z-2590-2018
- Recalling firm
- Envoy Medical Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-06-28
- Posted
- not on file
- Terminated
- 2020-11-03
- 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.
- Root cause
- Packaging process control
- Action
- The firm notified its customers via email on 06/18/2018 and 06/19/2018. The 06/18/2018 email to a customer stated Envoy Medical would like to have the devices the customer has on site returned, as apparently, it was confirmed that each device is packaged with a wipe that shows expired just on the wipe only. Envoy will replace the recalled devices by overnight shipping replacements. The 06/19/2018 email to a customer stated it was discovered that the sound processors (primary and backup) were previously sent to the site have a wipe in them that show an expired date on the packaging. The email also stated this is something that doesn't affect the actual sound processor itself as those are good, but just to be on the safe side, make sure the 2 sound processors currently at the site (serial #s 213658 and 213729) are returned to Envoy Medical ASAP so we can have them repackaged with wipes within their expiration dates added to the sound processor packaging. Envoy will send out 2 new Sound Processors (primary and backup). Both emails contained Envoy Medical contact information for the consignees in case any questions or concerns arose.
- Quantity
- 4 Units
- Distribution
- US Distribution to states of: FL, OR
- Lot, serial or model codes
- Lot Numbers: EMC0006145, EMC0006155, & EMC0006217
- 510(k) numbers
- not on file
- PMA numbers
- ["P090018"]
- Product code
- OAF
- Firm FEI
- 3004007782
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28