3B Medical, Inc. Recalls
3 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (3)
- Class II
February 4, 2026
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
- Class II
November 27, 2024
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 Concentrat
The devices were inadvertently shipped after their expiration date.
- Class II
June 15, 2023
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
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
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