---
title: "Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC8665... — FDA record Z-0125-2024 | Is It on Recall"
description: "The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling."
url: https://isitonrecall.com/recall/fda-device-z-0125-2024-gladiator-wrist-thumb-orthosis-part-numbers-nc86650-small-left-nc86651-small-right-nc86652-medium-le/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), ... — FDA record Z-0125-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
- **Classification**: Class II
- **Recalling firm**: North Coast Medical Inc
- **Quantity**: 27 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0125-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0125-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All Model Numbers without a manufacturing date on label |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Oct 25, 2023
- **Recall initiation date**: Aug 18, 2023
- **Center classification date**: Oct 19, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0125-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [North Coast Medical Inc records](https://isitonrecall.com/brand/north-coast-medical-inc/)