FDA recall Z-0828-2025

3B Medical, Inc. · Class II · device

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 for recall

The devices were inadvertently shipped after their expiration date.

Distribution

US: Massachusetts and Arkansas OUS: None

Key facts

Status: Ongoing
Initiation date: 2024-11-27
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winter Haven, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2025