AMD Medicom Inc.: Medical Device Recall in 2019 - (Recall #: Z-0494-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

Product Classification:

Class II

Date Initiated: October 11, 2019

Date Posted: November 27, 2019

Recall Number: Z-0494-2020

Event ID: 84118

Reason for Recall:

Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

Status: Terminated

Product Quantity: 756 cases (500 units/case)

Code Information:

Lot 1917

Distribution Pattern:

The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated