Food, drugs, devices › AMD Medicom Inc.
Device recall: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA enforcement event 84118 is a device recall by AMD Medicom Inc. of Lachine, N/A, initiated 11 Oct 2019 and classified Class II, with 2 product records.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 14 Sep 2021. Initiation: voluntary: firm initiated. AMD Medicom Inc. has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AMD Medicom Inc., Lachine, N/A, Canada.
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."
Distribution
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0494-2020 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | 756 cases (500 units/case) | Class II | Terminated | 27 Nov 2019 |
| Z-0495-2020 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 | 112 cases (500 units/case) | Class II | Terminated | 27 Nov 2019 |
Context
Other enforcement events for AMD Medicom Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 May 2026 | Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, N | Device | Class II | 2 |
| 21 Dec 2023 | HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) | Device | Class II | 3 |
All 3 events for AMD Medicom Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Sep 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.