Envoy Medical Corporation recalls Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018).…

Recall date

June 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2590-2018

FDA classification

Class II

Brand / firm

Envoy Medical Corporation

Sold / distributed

US Distribution to states of: FL, OR

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.