Ultrasoft Oxygen Cannula (3B Medical) – Expired Product (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
3B Medical, Inc. 203 Avenue A Nw Ste 300 Winter Haven FL 33881-4540
Lot Codes / Batch Numbers
Lot Code: Lot Number 20170403
Products Sold
Lot Code: Lot Number 20170403
3B Medical, Inc. 203 Avenue A Nw Ste 300 Winter Haven FL 33881-4540 is recalling Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: due to The devices were inadvertently shipped after their expiration date.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices were inadvertently shipped after their expiration date.
Recommended Action
Per FDA guidance
On November 27, 2024 3B Medical Inc., dba React Health issued a "Urgent: Medical Device Recall" notification to affected consignees via Email. On 12/5/2024 React Health provided an updated letter to affected consignees via USPS certified Mail. In addition to making the aware of the issue, React Health asked consignees to take the following steps: 1. Please confirm receipt of this notification letter by returning the enclosed Customer Response Form to 3B Medical, Inc., within 7 days, by US Mail or via attachment to e-Mail sent to christopher.wood@reacthealth.com. 2. Confirm that end users and customers have been contacted and instructed to stop using the affected cannulas. 3. Return the affected product to 3B Medical, Inc. dba React Health. 3B Medical, Inc., dba React Health will provide FedEx return labels or arrange for the shipping of the devices you have to return. 4. 3B Medical, Inc., dba React Health, has inventory to replace your devices and will place $0 orders to replace all the devices that were shipped to you expired. 5. Please acknowledge receipt of this notification and respond via the enclosed Customer Response Form within 7 days of receipt. 6. Adverse events, reactions. or quality issues experienced with the use of these devices may be reported to us at 3B Medical, Inc., dba React Health or via the FDA s MedWatch Adverse Event Reporting program.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, MA
Page updated: Jan 10, 2026