# FDA recall Z-0125-2024

> **North Coast Medical Inc** · Class II · device recall initiated 2023-08-18.

## Product

Gladiator, Wrist & Thumb Orthosis,  Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

## Reason for recall

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

## Distribution

US: NC, CA, WI OUS: New Zealand, Australia,

## Key facts

- **Recall number:** Z-0125-2024
- **Recalling firm:** North Coast Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-18
- **Report date:** 2023-10-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2024

## Citation

> AI Analytics. FDA recall Z-0125-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0125-2024. Source: US FDA. Licensed CC0.

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