# FDA recall Z-1493-2026

> **Advanced Bionics, LLC** · Class II · device recall initiated 2025-11-27.

## Product

Brand Name: HiResolution Bionic Ear System  Product Name: Sky CI M90 Sound Processor  Model/Catalog Number: CI-5295-150

## Reason for recall

Behind-the-ear sound processer  packaging  label is different then included product.

## Distribution

Unknown

## Key facts

- **Recall number:** Z-1493-2026
- **Recalling firm:** Advanced Bionics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-27
- **Report date:** 2026-03-11

- **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-1493-2026

## Citation

> AI Analytics. FDA recall Z-1493-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1493-2026. Source: US FDA. Licensed CC0.

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