CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report

Medicom Safemask Premier Plus Astm Level 3 Masks recalled by AMD Medicom

AMD Medicom is recalling Medicom Safemask Premier Plus Astm Level 3 Masks, distributed in 13 states. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1917

Quantity recalled112 cases (500 units/case)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0495-2020
FDA event ID: 84118
Recalling firm: AMD Medicom, Lachine, N/A
Classification: Class II
Status: Terminated
Recall initiated: 11 Oct 2019
FDA classified: 19 Nov 2019
Reported: 27 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Masks, Gloves & PPE

Timeline

11 Oct 2019	Recall initiated by company
19 Nov 2019	Classified by FDA	+39 days
27 Nov 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

Where it was distributed

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.

California Florida Iowa Indiana Maryland Michigan Nevada New York Pennsylvania South Carolina Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 1917

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84118

This product is part of a recall event; the main page for the event is Medicom Safemask Premier Plus Astm Level 2 Masks recalled by AMD Medicom.

Reported	Class	Recall	Company	Reason	Where
27 Nov 2019	CLASS II	Medicom Safemask Premier Plus Astm Level 2 Masks recalled by AMD Medicom	AMD Medicom	Packaging Defects	13 states

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