HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 — Class II medical device recall Z-1146-2024
Ongoing recall by AMD Medicom Inc., reported 2024-02-28, distributed nationwide. Level 3 masks were produced on alternate non-validated production equipment that were not included as part of
| Recall number | Z-1146-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMD Medicom Inc., Montreal, N/A, Canada |
| Recall initiated | 2023-12-21 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10304040142520 |
| Lot numbers | 2337, 2338, 2342, 2343, 2344 |
| Model numbers | 570-2448 |
Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
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.
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-1146-2024. 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.