[pending] HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Pending LLM rewrite. Source: FDA_DEVICE Z-1813-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
The recalled product
- Product
- HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Manufacturer
- Advanced Bionics, LLC
- Category
- Medical Device — Devices
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
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