FDA Device recall Z-1146-2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) by Amd Medicom, citing level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1146-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Amd Medicom |
| Distribution | US |
Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Reason
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Identifiers
| code_info | Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.