CLASS II Device recall · Reported 6 Feb 2013 · FDA Enforcement Report

Esteem Programmer recalled by Envoy Medical

Envoy Medical is recalling Esteem Programmer, distributed in 14 states. The recall was initiated on 9 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 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

Quantity recalled44

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0750-2013
FDA event ID: 63875
Recalling firm: Envoy Medical, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 9 Jan 2013
FDA classified: 30 Jan 2013
Reported: 6 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Medical Software

Timeline

9 Jan 2013	Recall initiated by company
30 Jan 2013	Classified by FDA	+21 days
6 Feb 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arizona California Connecticut Florida Georgia Illinois Massachusetts Michigan Minnesota North Carolina Oklahoma Rhode Island Texas

Questions about this recall

Is Esteem Programmer recalled?

Yes. Envoy Medical recalled Esteem Programmer on 9 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0750-2013.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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