Edwards Sterile Oxymetry Oligon Catheter Kit Recall: Packaging Compromised
Edwards Lifesciences recalls Sterile Oxymetry Oligon Catheter Kit (model XA3816SFKT) due to compromised packaging. Affected units have specific lot codes. Consumers should check their kit for packaging issues.
Lower-risk recall
Sterile catheter kit packaging compromised.
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling their Sterile Oxymetry Oligon Catheter Kit because the packaging may be compromised. This could lead to contamination risks if the kit is used without proper sterility. Affected units have specific lot codes listed in the recall. Read more at govinfonow.com/recall/65595-edwards-sterile-oxymetry-oligon-catheter-kit-recall-packaging-compromised.
Source Summary by GovInfoNow · govinfonow.com/recall/65595-edwards-sterile-oxymetry-oligon-catheter-kit-recall-packaging-compromised · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2007-2020
Cite this page
“Edwards Sterile Oxymetry Oligon Catheter Kit Recall: Packaging Compromised.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65595-edwards-sterile-oxymetry-oligon-catheter-kit-recall-packaging-compromised. Based on FDA recall #Z-2007-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2007-2020%22&limit=1).
Why it’s dangerous
The catheter kit packaging may be compromised, potentially leading to contamination. If the packaging is not properly sealed, the sterile components could be exposed to contaminants, increasing infection risk during medical procedures.
Who’s affected
Healthcare professionals and patients using the Sterile Oxymetry Oligon Catheter Kit for medical purposes. Those with the specific lot codes listed in the recall are most at risk.
How to tell if you have this one
Check the lot codes on the packaging: 62563142, 62157774, 62132722, 62749306, or 62625932. The product is a pressure injectable sterile catheter kit with the model number XA3816SFKT.
- Brand
Edwards Lifesciences- Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181- Category
Medical device
What to do — step by step
Check Packaging Integrity
Inspect the packaging for any signs of damage or compromised seals.
Where it went and when
Where it was distributed
Distributed in 15 states.
FDA distribution: “US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Missouri, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 13 months 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.
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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-2007-2020 (March 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2007-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.