Reported Mar 11, 2026 · Ongoing
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Advanced Bionics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics, LLC · 28515 Westinghouse Pl · Valencia, CA · 91355-1398
Is this the product you have?
- Brand NameHiResolution
- Bionic Ear System Product NameSky CI M90
- Sound Processor Model/Catalog NumberCI-5295-150
- Lot codes and dates
- Lot CodeUDI-DI: 08400944CI5295YJ
- Model NumberCI-5295-150
- Serial Numbers
249596249603
- Amount recalled
- 2 units
Why it was recalled
Behind-the-ear sound processer packaging label is different then included product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Advanced Bionics, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.