Gladiator — Class II medical device recall Z-0125-2024
Ongoing recall by North Coast Medical Inc, reported 2023-10-25, distributed in CA, NC, WI. The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling
| Recall number | Z-0125-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | North Coast Medical Inc, Morgan Hill, CA, United States |
| Recall initiated | 2023-08-18 |
| Classified | 2023-10-19 |
| Reported by FDA | 2023-10-25 |
| Distributed | CA, NC, WI |
| Countries outside the US | AU, NZ |
| Quantity | 27 units |
| Reason classes | undeclared allergen, labeling |
| Model numbers | NC86650 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0125-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.