North Coast Medical Gladiator Orthosis Recall: Latex Not Declared on Label
North Coast Medical recalls Gladiator wrist and thumb orthoses with unlisted latex in straps. Affected models have part numbers NC86650-NC86657 and no manufacturing date on label. Consumers should check their device for these identifiers.
Lower-risk recall
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Contact the company
What happened, in plain English
North Coast Medical is recalling wrist and thumb orthoses that may contain latex not listed on labels. This could cause allergic reactions in sensitive individuals who are exposed to the latex. The recall affects specific model numbers and devices without manufacturing dates. Read more at govinfonow.com/recall/57465-north-coast-medical-gladiator-orthosis-recall-latex-not-declared-on.
Source Summary by GovInfoNow · govinfonow.com/recall/57465-north-coast-medical-gladiator-orthosis-recall-latex-not-declared-on · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0125-2024
Cite this page
“North Coast Medical Gladiator Orthosis Recall: Latex Not Declared on Label.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57465-north-coast-medical-gladiator-orthosis-recall-latex-not-declared-on. Based on FDA recall #Z-0125-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0125-2024%22&limit=1).
Why it’s dangerous
The orthosis straps may contain latex that isn't declared on the product label. This poses a risk for individuals with latex allergies who could experience an allergic reaction when they come into contact with the device.
Who’s affected
People who own or use the recalled Gladiator wrist and thumb orthoses are most at risk if they have latex allergies. Those with known latex sensitivity should avoid using these devices.
How to tell if you have this one
Check for part numbers NC86650 through NC86657 on the device. The affected models also lack a manufacturing date on the label.
- Brand
North Coast Medical- Category
Medical device
What to do — step by step
Check Device Labels
Look for part numbers NC86650 through NC86657 and the absence of a manufacturing date on the label.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “US: NC, CA, WI OUS: New Zealand, Australia,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, North Carolina, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0125-2024 (August 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0125-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.