# FDA recall Z-2287-2025

> **Spark Biomedical Inc** · Class II · device recall initiated 2025-07-02.

## Product

Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

## Reason for recall

Due to manufacturing issue, neurostimulator device may experience  "cable disconnect" error message and interruption to stimulation output.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2287-2025
- **Recalling firm:** Spark Biomedical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-02
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2025

## Citation

> AI Analytics. FDA recall Z-2287-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2287-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*