3B Medical Ultrasoft Oxygen Cannula Recall: Expired Product Risk
3B Medical recalls expired Ultrasoft Oxygen Cannula (Model O2U2012) due to potential safety issues from expired lot. Learn if you have affected units and what to do.
Lower-risk recall
The devices were inadvertently shipped after their expiration date.
Contact the company
What happened, in plain English
3B Medical is recalling expired Ultrasoft Oxygen Cannulas (Model O2U2012) that were shipped after their expiration date. Using expired medical devices can lead to safety risks, especially for patients relying on oxygen therapy. Read more at govinfonow.com/recall/53380-3b-medical-ultrasoft-oxygen-cannula-recall-expired-product-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53380-3b-medical-ultrasoft-oxygen-cannula-recall-expired-product-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0828-2025
Cite this page
“3B Medical Ultrasoft Oxygen Cannula Recall: Expired Product Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53380-3b-medical-ultrasoft-oxygen-cannula-recall-expired-product-risk. Based on FDA recall #Z-0828-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2025%22&limit=1).
Why it’s dangerous
Medical devices that expire can become unsafe for use. Oxygen cannulas that are past their expiration date may not function properly, potentially leading to inadequate oxygen delivery or other safety issues.
Who’s affected
Patients using oxygen therapy with this specific cannula model are most at risk. Anyone who purchased the expired lot number 20170403 from 3B Medical is affected.
How to tell if you have this one
Check for the model number O2U2012 and lot number 20170403 on the product. This expired cannula is for nasal oxygen use with concentrators.
- Brand
3B Medical- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number O2U2012 and lot number 20170403 on the cannula.
Where it went and when
Where it was distributed
Distributed in Arkansas and Massachusetts.
FDA distribution: “US: Massachusetts and Arkansas OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, Massachusetts.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other 3B Medical recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0828-2025 (November 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0828-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.