# FDA recall Z-1813-2025

> **Advanced Bionics, LLC** · Class II · device recall initiated 2025-03-05.

## 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.

## Distribution

U.S.: AZ, FL, MI, SC, TN and TX.  O.U.S.: N/A

## Key facts

- **Recall number:** Z-1813-2025
- **Recalling firm:** Advanced Bionics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-05
- **Report date:** 2025-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2025

## Citation

> AI Analytics. FDA recall Z-1813-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1813-2025. Source: US FDA. Licensed CC0.

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