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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Related recalls
Same manufacturer · Envoy Medical Corporation
See all →- ModerateEnvoy Medical Recalls Esteem Programmers for Noise Interference
FDA (Devices) · 2013-02-06
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateEnvoy Medical Recalls Esteem Programmers for Noise Interference
FDA (Devices) · 2013-02-06
- ModerateEXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
FDA (Devices) · 2015-08-05
- HighEthicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise
FDA (Devices) · 2013-07-31
- HighEXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters
FDA (Devices) · 2015-08-05