FDA Device recall Z-0828-2025
Brand Name: 3B Medical, Inc
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Brand Name: 3B Medical, Inc by 3b Medical, citing the devices were inadvertently shipped after their expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-27 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | 3b Medical |
| Distribution | AR, MA |
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
The devices were inadvertently shipped after their expiration date.
Identifiers
| code_info | Lot Code: Lot Number 20170403 |
|---|
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-0828-2025%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.