Z-0828-2025Class II

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

Name: Z-0828-2025 Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012...
Creator: 3B Medical, Inc.
Published: 2024-11-27
License: https://open.fda.gov/license/

3B Medical Inc / initiated 2024-11-27 / Open, Classified / root cause: manufacturing process

FDA source

3B Medical, Inc. began a recall of Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal... on 2024-11-27. FDA classified it as Class II and gives the reason as "The devices were inadvertently shipped after their expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0828-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-27
Posted: 2025-01-08
Recalling firm: 3B Medical Inc
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
Product code: BZB Catheter, Nasal, Oxygen
Reason for recall: The devices were inadvertently shipped after their expiration date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected]. 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.
Quantity in commerce: 5010 units
Distribution: US: Massachusetts and Arkansas OUS: None
Product codes and lots: Lot Code: Lot Number 20170403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-08

Product code BZB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)