Atrium Oasis Drain Single W / AC — Class II medical device recall Z-0621-2024
Ongoing recall by Atrium Medical Corporation, reported 2024-01-03, distributed nationwide. A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on
| Recall number | Z-0621-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-11-01 |
| Classified | 2023-12-28 |
| Reported by FDA | 2024-01-03 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00650862110012 |
| Lot numbers | 492065, 492075 |
| Model numbers | 3600-100 |
Product
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Reason for recall
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
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-0621-2024. 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.