AMD Medicom Inc.: Medical Device Recall in 2024 - (Recall #: Z-1146-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

Product Classification:

Class II

Date Initiated: December 21, 2023

Date Posted: February 28, 2024

Recall Number: Z-1146-2024

Event ID: 93818

Reason for Recall:

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

Status: Ongoing

Product Quantity: 720 cases (10 boxes/case and 50 masks/box)

Code Information:

Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;

Distribution Pattern:

US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.

Voluntary or Mandated:

Voluntary: Firm initiated