Class II — North Coast Medical Inc
| Recalling firm | NORTH COAST MEDICAL, INC. |
|---|---|
| Registered facility | NORTH COAST MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
| 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) |
| Quantity | 27 units |
| Distribution | US: NC, CA, WI OUS: New Zealand, Australia, |
| Initiated | 2023-08-18 |
| Classified | 2023-10-19 |
| Recall number | Z-0125-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — North Coast Medical Inc (Z-0125-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93079/
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