Recall Atlas

3B Medical recalls

3 official recalls and safety alerts involving 3B Medical since 2025-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with 3B Medical or the relevant agency.

  1. 2026-07-22
  2. US
    Drugs & medicalClass II

    3B Medical, Inc. recalls Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)…

    Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

    FDA · Device3B Medical, Inc.US Nationwide distribution.Official notice →
  3. 2026-04-22
  4. US
    Drugs & medicalClass II

    3B Medical, Inc. recalls React Health PHOENIX 5L Oxygen Concentrator

    Devices which did not meet internal quality specifications were inadvertently distributed.

    FDA · Device3B Medical, Inc.US Nationwide distribution in the state of NY.Official notice →
  5. 2025-01-15
  6. US
    Drugs & medicalClass II

    3B Medical, Inc. recalls Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product…

    The devices were inadvertently shipped after their expiration date.

    FDA · Device3B Medical, Inc.US: Massachusetts and Arkansas OUS: NoneOfficial notice →