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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling discrepancy regarding expiration dates without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Envoy Medical Corporation is recalling four units of the Esteem II Sound Processor Model 2001. The recall involves the Final Pack, which contains two sterile wipes (002866-001) that expired in April 2018. The expiration date on the sterile wipes is earlier than the expiration date labeled on the final pack and the sound processors themselves.
The affected units are identified by lot numbers EMC0006145, EMC0006155, and EMC0006217. These devices were distributed in the United States to the states of Florida and Oregon. The Esteem II is an implantable middle ear hearing device.
Consumers who have these specific units should contact Envoy Medical Corporation for instructions on how to proceed. The recall is due to the discrepancy between the expiration date of the sterile wipes and the labeled expiration date of the final pack.
The recalled product
- 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.
- Manufacturer
- Envoy Medical Corporation
- Category
- Medical Device — Hearing Aids
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: EMC0006145
- EMC0006155
- & EMC0006217
Distribution
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