FDA Device recall Z-0125-2024
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right)…
- FDA Device
- Class II
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right)… by North Coast Medical, citing the thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0125-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-18 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | North Coast Medical |
| Distribution | CA, NC, WI |
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.
Identifiers
| code_info | All Model Numbers without a manufacturing date on label |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0125-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.