# FDA recall Z-1147-2024

> **AMD Medicom Inc.** · Class II · device recall initiated 2023-12-21.

## Product

HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

## Reason for recall

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

## Distribution

US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.

## Key facts

- **Recall number:** Z-1147-2024
- **Recalling firm:** AMD Medicom Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-21
- **Report date:** 2024-02-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2024

## Citation

> AI Analytics. FDA recall Z-1147-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1147-2024. Source: US FDA. Licensed CC0.

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