FDA Medical devices recall ·
3B Medical, Inc recall
- Recall number
- Z-0828-2025
- Date
- (initiated November 27, 2024)
- Company / brand
- 3B Medical, Inc.
203 Avenue A Nw Ste 300, Winter Haven, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5010 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The devices were inadvertently shipped after their expiration date.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot Number 20170403
Distribution
US: Massachusetts and Arkansas OUS: None
States: Arkansas Massachusetts
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0828-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.