Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.