Facility

ENVOY MEDICAL CORPORATION

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

4inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004007782
Establishment type	Manufacture Medical Device
Location	4875 White Bear Pkwy White Bear Lake, MN, US 55110
Registration status	Active · expires 2026
Parent company	ENVOY MEDICAL CORPORATION (owner-operator 9092560)
Brand names	Esteem

Activity by year

Recalls (2)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Implant, Hearing, Active, Middle Ear, Totally Implanted
Product code OAF (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IITerminated2018-06-28
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 IITerminated2013-01-09
Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.

FDA inspections (4)

NAI2025-07-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-02-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-02-14
No Action Indicated · Compliance: Devices; Project Evaluation: Devices; Postmarket Assurance: Devices
NAI2016-10-27
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2025-11-13
Warning Letter (opens in a new tab) · Saint Paul Minnesota

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by ENVOY MEDICAL CORPORATION

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ENVOY MEDICAL CORPORATION (FEI 3004007782) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004007782-envoy-medical-corporation/

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