Envoy Medical recalls Esteem II Sound Processors with expired sterile wipes. The wipes expired before their labeled date, posing a risk of infection. Consumers should check product details and contact Envoy for guidance.
Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
Envoy Medical is recalling hearing devices that include expired sterile wipes. These wipes expired before their labeled date, which could lead to infection risks if used improperly.
Sterile wipes in these hearing devices expired earlier than the labeled date. This means the wipes may not be effective for cleaning or preventing infections, especially if used during device maintenance.
Hearing device users who own the specific Esteem II Sound Processor Model 2001 with lot numbers EMC0006145, EMC0006155, or EMC0006217 are affected. People using these devices for hearing aid purposes are most at risk.
Check for the product name 'Esteem II Sound Processor Model 2001' and lot numbers EMC0006145, EMC0006155, or EMC0006217. The wipes expired in April 2018, but the final pack's expiration date was later.
Identify if your hearing device has the specific lot numbers EMC0006145, EMC0006155, or EMC0006217.
The sterile wipes expired earlier than their labeled date, which could lead to reduced effectiveness and potential infection risks during device maintenance.
No, the recall does not require immediate discontinuation. Check the product details and contact Envoy Medical for further guidance.
Look for the product name 'Esteem II Sound Processor Model 2001' and lot numbers EMC0006145, EMC0006155, or EMC0006217 on the device packaging.
We’ve drafted a message you can send Envoy Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2590-2018 — Envoy Medical Envoy Medical Hello, I own a Envoy Medical that is covered by recall Z-2590-2018 from Envoy Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
