Gladiator recall: Labeling Error
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654…
Why was Gladiator recalled?
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Model Numbers without a manufacturing date on label
- Product
- Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654…
- Recalling firm
- North Coast Medical Inc
- Quantity
- 27 units
- Distribution
- US: NC, CA, WI OUS: New Zealand, Australia,
- Recall date
- October 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)