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Envoy Medical recalls

Envoy Medical has 2 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 8 Aug 2018. The most frequent reason is packaging defects.

Total recalls2since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Aug 2018

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why envoy medical is recalled

Packaging Defects150%
Sterility150%

Product types

Other Medical Devices150%
Medical Software150%

By year

2018150%
2013150%

All envoy medical recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018Device	CLASS II	Final Pack, Esteem II, Sound Processor recalled by Envoy Medical	Envoy Medical	Sterility	FL, OR
6 Feb 2013Device	CLASS II	Esteem Programmer recalled by Envoy Medical	Envoy Medical	Packaging Defects	14 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.