3B Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0828-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 27, 2024

Date Posted: January 15, 2025

Recall Number: Z-0828-2025

Event ID: 95918

Reason for Recall:

The devices were inadvertently shipped after their expiration date.

Status: Ongoing

Product Quantity: 5010 units

Code Information:

Lot Code: Lot Number 20170403

Distribution Pattern:

US: Massachusetts and Arkansas OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated