Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 Recalled by Highland Metals, Inc. Due to Labeling issue: Product labeled as "Upper" may contain...

Date: December 13, 2013
Company: Highland Metals, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Highland Metals, Inc. directly.

Affected Products

SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

Quantity: 37 packages

Why Was This Recalled?

Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

Where Was This Sold?

This product was distributed to 7 states: CA, FL, IL, KY, LA, MI, NY

Affected (7 states)Not affected

About Highland Metals, Inc.

Highland Metals, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report