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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

North Coast Medical Inc: Gladiator Wrist & Thumb Orthosis Recalled for Undeclared Latex

Agency Publication Date: October 19, 2023
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Summary

North Coast Medical Inc. is recalling 27 units of the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that was not declared on the product label. This recall affects various sizes (Small through X-Large) for both left and right hands. Consumers who have a latex allergy or sensitivity could experience an allergic reaction when using these braces. The affected products can be identified by the absence of a manufacturing date on the product label.

Risk

The thumb strap contains latex that is not listed on the packaging, which can cause serious allergic reactions in individuals with latex sensitivities or allergies upon skin contact.

What You Should Do

  1. Check your Gladiator Wrist & Thumb Orthosis packaging and product label for a manufacturing date; if the label has no manufacturing date, it is included in this recall.
  2. Verify if your orthosis matches one of the following part numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), or NC86657 (X-Large/Right).
  3. If you have a latex allergy or sensitivity, stop using the orthosis immediately to avoid a potential allergic reaction.
  4. Contact your healthcare provider or North Coast Medical Inc. at 1-800-821-9319 for further instructions regarding the affected product and a potential refund.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Gladiator, Wrist & Thumb Orthosis (Small/Left)
Model / REF:
NC86650
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (Small/Right)
Model / REF:
NC86651
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (Medium/Left)
Model / REF:
NC86652
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (Medium/Right)
Model / REF:
NC86653
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (Large/Left)
Model / REF:
NC86654
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (Large/Right)
Model / REF:
NC86655
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (X-Large/Left)
Model / REF:
NC86656
Date Ranges: All Model Numbers without a manufacturing date on label
Product: Gladiator, Wrist & Thumb Orthosis (X-Large/Right)
Model / REF:
NC86657
Date Ranges: All Model Numbers without a manufacturing date on label

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93079
Status: Active
Manufacturer: North Coast Medical Inc
Manufactured In: United States
Units Affected: 27 units
Distributed To: North Carolina, California, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.