HiResolution" Bionic Ear System — Class II medical device recall Z-1813-2025
Ongoing recall by Advanced Bionics, LLC, reported 2025-05-28, distributed in AZ, FL, MI, SC, TN, TX. Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the inten
| Recall number | Z-1813-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2025-03-05 |
| Classified | 2025-05-22 |
| Reported by FDA | 2025-05-28 |
| Distributed | AZ, FL, MI, SC, TN, TX |
| Quantity | 6 chargers |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840094433977 |
| Lot numbers | 410488966, 410488967 |
| Model numbers | CI-5607 |
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Reason for recall
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1813-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.