Atrium Oasis Dry Suction Water Seal Chest Drain — Class II medical device recall Z-0485-2024
Ongoing recall by Atrium Medical Corporation, reported 2023-12-13. Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization
| Recall number | Z-0485-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-09-05 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 20650862110016 |
| Lot numbers | 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762 |
| Model numbers | 3600-100 |
Product
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Reason for recall
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
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-0485-2024. 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.