Envoy Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2590-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 28, 2018

Date Posted: August 8, 2018

Recall Number: Z-2590-2018

Event ID: 80489

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.

Status: Terminated

Product Quantity: 4 Units

Code Information:

Lot Numbers: EMC0006145, EMC0006155, & EMC0006217

Distribution Pattern:

US Distribution to states of: FL, OR

Voluntary or Mandated:

Voluntary: Firm initiated