North Coast Medical Inc: Medical Device Recall in 2023 - (Recall #: Z-0125-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: August 18, 2023

Date Posted: October 25, 2023

Recall Number: Z-0125-2024

Event ID: 93079

Reason for Recall:

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

Status: Ongoing

Product Quantity: 27 units

Code Information:

All Model Numbers without a manufacturing date on label

Distribution Pattern:

US: NC, CA, WI OUS: New Zealand, Australia,

Voluntary or Mandated:

Voluntary: Firm initiated