HiResolution Sky CI M90 Sound Processor Recall: Packaging Label Mismatch
HiResolution recalls Sky CI M90 Sound Processors with mismatched packaging labels. Affected units may have incorrect labeling; contact for remedy.
Lower-risk recall
Behind-the-ear sound processer packaging label is different then included product.
Contact the company
What happened, in plain English
HiResolution is recalling Sky CI M90 Sound Processors due to packaging labels not matching the actual product. This mismatch could lead to confusion about the device's specifications. Read more at govinfonow.com/recall/50582-hiresolution-sky-ci-m90-sound-processor-recall-packaging-label-mismatch.
Source Summary by GovInfoNow · govinfonow.com/recall/50582-hiresolution-sky-ci-m90-sound-processor-recall-packaging-label-mismatch · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1493-2026
Cite this page
“HiResolution Sky CI M90 Sound Processor Recall: Packaging Label Mismatch.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50582-hiresolution-sky-ci-m90-sound-processor-recall-packaging-label-mismatch. Based on FDA recall #Z-1493-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2026%22&limit=1).
Why it’s dangerous
The packaging label differs from the actual product, which may cause confusion about the device's specifications. This mismatch does not involve physical harm but could lead to incorrect usage or misunderstandings.
Who’s affected
Users of the Sky CI M90 Sound Processor with model CI-5295-150 and serial numbers 249596 or 2:49603 are affected. People who rely on these devices for hearing assistance are most at risk.
How to tell if you have this one
Check for model number CI-5295-150 and serial numbers 249596 or 249603 on the device. The packaging label should match the product description.
- Brand
HiResolution- Category
Medical device
What to do — step by step
Check Product Label
Verify the model number and serial numbers on the device to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1493-2026 (November 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1493-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.