The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0495-2020·Announced 2019-11-27

AMD Medicom Recalls Level 3 Masks Due to Packaging Error

AMD Medicom is recalling Level 3 masks because Level 2 masks may have been packed in Level 3 boxes. The masks are visually indistinguishable, creating a risk of using lower protection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential use of lower protection levels.

Plain-English summary

AMD Medicom Inc. is recalling MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042, Lot 1917. The recall involves 112 cases, with 500 units per case. The products were distributed to the US states of CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA, as well as to Canada.

The recall is due to an error on the packaging line where some Level 2 masks may have been packed in Level 3 mask boxes. Because the two masks are visually indistinguishable, there is a risk that users may utilize a mask with a lower protection level than intended.

Consumers who have purchased these masks should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
Manufacturer
AMD Medicom Inc.
Category
Medical Device — Personal Protective Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1917

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by AMD Medicom Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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