Class II — Potential Health Hazard

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

HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item Recalled by AMD Medicom Inc. Due to Level 3 masks were produced on alternate non-validated...

Date: December 21, 2023
Company: AMD Medicom Inc.
Status: Ongoing
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 AMD Medicom Inc. directly.

Affected Products

HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

Quantity: 960 cases (10 boxes/case and 50 masks/box)

Why Was This Recalled?

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AMD Medicom Inc.

AMD Medicom Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

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