OriGen Reinforced Dual Lumen Cannula Recall: Endotoxin Testing Failure
OriGen Biomedical recalls reinforced dual lumen cannulas due to failed endotoxin testing. Affected units have specific model and lot numbers. Consumers should contact for details.
Recall notice
The catheter failed the endotoxin testing.
Contact the company
What happened, in plain English
OriGen Biomedical is recalling reinforced dual lumen cannulas that failed endotoxin testing. This could pose a risk of infection or other complications if used in medical procedures. Read more at govinfonow.com/recall/70002-origen-reinforced-dual-lumen-cannula-recall-endotoxin-testing-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/70002-origen-reinforced-dual-lumen-cannula-recall-endotoxin-testing-failure · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0102-2019
Cite this page
“OriGen Reinforced Dual Lumen Cannula Recall: Endotoxin Testing Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70002-origen-reinforced-dual-lumen-cannula-recall-endotoxin-testing-failure. Based on FDA recall #Z-0102-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0102-2019%22&limit=1).
Why it’s dangerous
Endotoxins are toxic substances found in the outer membrane of bacteria. If the cannula failed endotoxin testing, it could introduce harmful bacteria into the bloodstream during medical procedures, potentially causing infections or other complications.
Who’s affected
Healthcare professionals using the cannulas for ECMO or other medical procedures are most at risk. Patients receiving these cannulas may also be affected.
How to tell if you have this one
Check for the model number VV13F, lot number N18687-1, and unique device identifier 00816203022059 on the cannula packaging or label.
- Brand
OriGen Biomedical- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number VV13F, lot number N18687-1, and unique device identifier 00816203022059 on the cannula packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 25 states.
FDA distribution: “US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Maryland, Massachusetts, Michigan, Missouri, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this cannula?
The recall record does not describe a specific hazard mechanism that would cause serious injury, so the risk level is unknown.
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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-0102-2019 (August 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0102-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.