Lower riskMedical device recall · FDA · Published October 11, 2019
Medicom Premier Plus Level 2 Masks Recalled Due to Incorrect Packaging
Medicom recalls Level :2 masks (Item 2040) that may be in Level 3 boxes. Using these masks risks lower protection than intended. Affected masks were sold with Lot 1917.
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.
“Medicom Premier Plus Level 2 Masks Recalled Due to Incorrect Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66802-medicom-premier-plus-level-2-masks-recalled-due-to-incorrect. Based on FDA recall #Z-0494-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0494-2020%22&limit=1).
AMD Medicom Inc. recalled MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040, Lot 1917, because some were packed in level 3 mask boxes, posing a risk of using a lower protection level than intended, the FDA said on Oct. 11, 2019.
How to tell if you have it
Brand: Medicom
Product: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS
Item Code: 2040
Lot: 1917
Quantity: 756 cases (500 units/case)
Distribution: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, WA, and Canada
The hazard
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.
Context
GovInfoNow's records show AMD Medicom Inc. has 2 other recalls on record since 2023-12-21. Other recent recalls of similar products include MediHoney Gel Dressing Recall (2026-01-16), AVID Medical Halyard Major Pack Recall (2025-11-14), and Medline Convenience Kits Recall (2026-06-12).
How to tell if you have this one
Check for the Item Code 2040 and Lot 1917 on the mask packaging. The masks were sold in boxes labeled as Level 3 but contain Level 2 masks.
Brand
Medicom
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0494-2020
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040; Lot 1917
756 cases (500 units/case)
Z-0495-2020
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042; Lot 1917
112 cases (500 units/case)
Based on the official FDA remedy
What to do — step by step
Check Mask Packaging
Look for Item Code 2040 and Lot 1917 on the mask packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Indiana, Iowa, Maryland, Michigan, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0494-2020 (October 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0494-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.