FDA Device recall Z-0495-2020
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 by Amd Medicom, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0495-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-11 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Amd Medicom |
| Distribution | CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, WA |
Product
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
Reason
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.
Identifiers
| code_info | Lot 1917 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0495-2020%22
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