Z-2590-2018Class II

Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in...

Name: Z-2590-2018 Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in...
Creator: Envoy Medical Corporation
Published: 2018-06-28
License: https://open.fda.gov/license/

Envoy Medical Corporation / initiated 2018-06-28 / Terminated / root cause: packaging

FDA source

Envoy Medical Corporation began a recall of 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 on 2018-06-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2590-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-28
Posted: 2018-08-01
Terminated: 2020-11-03
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.
Product code: OAF Implant, Hearing, Active, Middle Ear, Totally Implanted
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 4 Units
Distribution: US Distribution to states of: FL, OR
Product codes and lots: Lot Numbers: EMC0006145, EMC0006155, & EMC0006217

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2590-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2590-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-01

Product code OAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)