Surgical Innovations YelloPort Elite Universal Seal Recall: Packaging Sterility Risk
Surgical Innovations recalls YelloPort Elite Universal Seals for potential packaging holes that could compromise sterility during laparoscopic surgery. Affected units include all lots with UDI/DI:0505198:001562.
Lower-risk recall
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Contact the company
What happened, in plain English
Surgical Innovations is recalling YelloPort Elite Universal Seals used in laparoscopic procedures because their packaging might have small holes that could affect sterility. This risk could lead to infections during surgery if the seal isn't properly sterile. Read more at govinfonow.com/recall/60562-surgical-innovations-yelloport-elite-universal-seal-recall-packaging-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60562-surgical-innovations-yelloport-elite-universal-seal-recall-packaging-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1396-2022
Cite this page
“Surgical Innovations YelloPort Elite Universal Seal Recall: Packaging Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60562-surgical-innovations-yelloport-elite-universal-seal-recall-packaging-sterility-risk. Based on FDA recall #Z-1396-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2022%22&limit=1).
Why it’s dangerous
The packaging may have small holes that could compromise the sterility of the seal. If the seal isn't sterile, it could lead to infections during surgery. This is a potential risk but not guaranteed to happen.
Who’s affected
Surgical professionals using YelloPort Elite Universal Seals for laparoscopic procedures are most at risk. All units with the UDI/DI:05051986001562 are affected.
How to tell if you have this one
Check for the product name 'YelloPort Elite Universal Seal' used in laparoscopic procedures. All lots with UDI/DI:05051986001562 are affected.
- Brand
Surgical Innovations- Category
Medical device
What to do — step by step
Check Packaging Integrity
Inspect the packaging for small holes that might compromise sterility.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, IN, WA, MA and the countries of Armenia, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Ecuador, UK, Finland, France, Germany, Greece, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Indiana, Massachusetts, Washington.
Recall timeline
FDA published this recall 55 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.
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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-1396-2022 (June 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1396-2022 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.