Dublin, OH, United States
3B Medical, Inc. recalls
3 recalls recorded since 2018, most recently on 4 February 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 February 2026
- Reason
- Devices which did not meet internal quality specifications were inadvertently distributed.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1815-2026
- React Health PHOENIX 5L Oxygen Concentrator
Ongoing Class II Medical devices
- Recall started
- 27 November 2024
- Reason
- The devices were inadvertently shipped after their expiration date.
- Distribution
- US: Massachusetts and Arkansas OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0828-2025
- 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
Ongoing Class II Medical devices
- Recall started
- 15 June 2023
- Reason
- Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2740-2026
- Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended f
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.