MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS — Class II medical device recall Z-0495-2020
Terminated recall by AMD Medicom Inc., reported 2019-11-27, distributed in CA, FL, IA, IN, MD, MI, NV, NY…. Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The
| Recall number | Z-0495-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMD Medicom Inc., Lachine, N/A, Canada |
| Recall initiated | 2019-10-11 |
| Classified | 2019-11-19 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2021-09-14 |
| Distributed | CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, WA |
| Countries outside the US | CA |
| Lot numbers | 1917 |
| Model numbers | 2042 |
Product
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0495-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.