HiResolution Bionic Ear System M Battery Charger Labeling Mismatch Recall
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling/packaging mismatch issue with no reported illnesses or injuries. The source text does not indicate any clinical harm or functional defect in the device itself, only a discrepancy between labeling and the actual product, which falls under minor labeling errors or packaging issues.
Plain-English summary
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger, Model Number CI-5607 (UDI-DI code 00840094433977, Lot Numbers 410488966 and 410488967). The recall was initiated because the battery charger was incorrectly packaged and distributed with product labeling that does not match the intended product as specified.
The affected chargers were distributed in the United States across Arizona, Florida, Michigan, South Carolina, Tennessee, and Texas.
Patients and healthcare providers who have received this device should verify that the product labeling matches the actual device received. Those with questions or concerns should contact the manufacturer directly for guidance regarding their specific device.
The recalled product
- Product
- HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Manufacturer
- Advanced Bionics, LLC
- Hazard
- labeling-mismatch
- packaging-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 410488967
Distribution
Distributed in 6 states:
- AZ
- FL
- MI
- SC
- TN
- TX
Related recalls
Same category
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22