Brand Name: 3B Medical — Class II medical device recall Z-0828-2025
Ongoing recall by 3B Medical, Inc., reported 2025-01-15, distributed in AR, MA. The devices were inadvertently shipped after their expiration date.
| Recall number | Z-0828-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3B Medical, Inc., Winter Haven, FL, United States |
| Recall initiated | 2024-11-27 |
| Classified | 2025-01-08 |
| Reported by FDA | 2025-01-15 |
| Distributed | AR, MA |
| Quantity | 5,010 units |
| Lot numbers | 20170403 |
| Model numbers | O2U2012 |
Product
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
Reason for recall
The devices were inadvertently shipped after their expiration date.
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-0828-2025. 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.