Reported Oct 25, 2023 · Ongoing

Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left),…

North Coast Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: North Coast Medical Inc · 135 E Main Ave Ste 110 · Morgan Hill, CA · 95037-7522

Is this the product you have?

  • 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)
Lot codes and dates
  • All Model Numbers without a manufacturing date on label
Amount recalled
27 units

Where it was sold

Why it was recalled

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.