# FDA recall Z-0495-2020

> **AMD Medicom Inc.** · Class II · device recall initiated 2019-10-11.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0495-2020
- **Recalling firm:** AMD Medicom Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-11
- **Report date:** 2019-11-27
- **Termination date:** 2021-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lachine, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0495-2020

## Citation

> AI Analytics. FDA recall Z-0495-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0495-2020. Source: US FDA. Licensed CC0.

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