Quick Facts at a Glance
- Recall Date
- November 27, 2025
- Hazard Level
- HIGH
- Brand
- Advanced Bionics
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, CHILDREN
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Advanced Bionics
- Product type
- Behind-the-ear sound processor
- Model numbers
- CI-5295-150, UDI-DI: 08400944CI5295YJ, Serial Numbers: 249596, Serial Numbers: 249603
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 27, 2025
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Behind-the-ear sound processer packaging label is different then included product.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Advanced Bionics, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The Sky CI M90 is a behind-the-ear sound processor used with cochlear implant systems. Recipients rely on accurate labeling to ensure proper device pairing and function.
Why This Is Dangerous
Labeling mismatches can lead to incorrect device identification and improper use, potentially affecting device performance.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The issue creates immediate use uncertainty for recipients and clinicians. There is potential for disruption in therapy if misidentified devices are used.
Practical Guidance
How to identify if yours is affected
- Verify the model number CI-5295-150 on the device and packaging.
- Inspect the UDI-DI on the label: 08400944CI5295YJ.
- Check Serial Numbers: 249596 and 249603.
Where to find product info
Serial numbers and model information are on the device and its packaging. The FDA recall page provides official details.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after verification and request submission.
If the manufacturer is unresponsive
- Escalate to the FDA recall process.
- Consult your healthcare provider for guidance.
- Document all communications and seek support from patient advocacy groups if needed.
How to prevent similar issues
- Always verify packaging labeling against the product before use.
- Keep a copy of the official recall notice for reference.
- Ask healthcare providers to confirm device compatibility during replacements.
Documentation advice
Save recall notice, take photos of the packaging label and device, keep serial numbers, and record all correspondence with the manufacturer.
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Product Details
Brand/Manufacturer: Advanced Bionics. Product: Sky CI M90 behind-the-ear sound processor. Model/Catalog Number: CI-5295-150. Lot/UDI: UDI-DI 08400944CI5295YJ. Serial Numbers: 249596, 249603. Quantity recalled: 2 units. Distribution: Unknown. Sold/When Sold: Unknown. Recalled by: FDA enforcement action. Recall date: 2025-11-27.
Key Facts
- UDI-DI: 08400944CI5295YJ
- Serial Numbers: 249596 and 249603
- Hazard: packaging label mismatch
- Remedy: stop use and follow manufacturer instructions
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Safety Guide
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