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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63875

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 09, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Envoy Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0750-2013
Recall number
Z-0750-2013
Initiated
January 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Envoy Medical Corporation
Quantity
44

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053 Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510 Lot# EMC0004304 EMC0004797 Lot# EMC0003827 EMC0004233

Distribution pattern

Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.