The Recall Desk

Manufacturer

Envoy Medical Corporation

2 recalls in our database name Envoy Medical Corporation as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2018-08-08

Of the 2 recalls from Envoy Medical Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-2590-2018·2018-08-08

    Envoy Medical Recalls Esteem II Sound Processors with Expired Sterile Wipes

    Envoy Medical is recalling four Esteem II Sound Processors because the sterile wipes inside expired before the date labeled on the final pack.

    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.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0750-2013·2013-02-06

    Envoy Medical Recalls Esteem Programmers for Noise Interference

    Envoy Medical is voluntarily correcting 44 Esteem Programmers to reduce susceptibility to noise interference.

    Product
    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
    Category
    Medical Device
    Distribution
    14 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Envoy Medical Corporation

Source: Wikidata (Q140309816), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.