Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Final Pack Recalled by Envoy Medical Corporation Due to Sterile Wipes packed in these four Esteem II...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Envoy Medical Corporation directly.
Affected Products
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.
Quantity: 4 Units
Why Was This 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.
Where Was This Sold?
This product was distributed to 2 states: FL, OR
About Envoy Medical Corporation
Envoy Medical Corporation has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report