Recall archive / FDA device enforcement
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 — FDA record Z-1813-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Reason
- Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- Classification
- Class II
- Recalling firm
- Advanced Bionics, LLC
- Quantity
- 6 chargers
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1813-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 28, 2025
- Recall initiation date
- Mar 5, 2025
- Center classification date
- May 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.