HiResolution recalls HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants due to incorrect shelf-life expiration dates. Affected units may expire prematurely, leading to potential product failure.
Due to incorrect shelf-life expiration date.
HiResolution is recalling its HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants because they have incorrect shelf-life expiration dates. This could cause the implants to expire prematurely, potentially leading to product failure.
The implants have incorrect expiration dates on their shelf life, which could cause them to expire prematurely. This might lead to the product failing before its intended use period ends.
Individuals with severe-to-profound hearing loss who use HiResolution's HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the model number CI-1601-04 on the implant. Affected units include specific lot numbers listed in the recall notice, such as 2225141, 2225150, and others.
Look for the model number CI-1601-04 on the implant to confirm if it is affected.
The recall is due to incorrect shelf-life expiration dates on the product, which could cause premature expiration and potential product failure.
Check the model number and lot numbers listed in the recall notice to see if your product is affected. If it is, contact HiResolution for further instructions.
Affected products have the model number CI-1601-04 and specific lot numbers listed in the recall, such as 2225141, 2225150, and others.
We’ve drafted a message you can send HiResolution to request your refund or repair — edit it as you like.
Subject: Recall Z-2283-2026 — HiResolution HiResolution Hello, I own a HiResolution that is covered by recall Z-2283-2026 from HiResolution. 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.
