Recall archive / FDA device enforcement
YelloPort Elite Universal Seal. For use in laparoscopic procedures. — FDA record Z-1396-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- YelloPort Elite Universal Seal. For use in laparoscopic procedures.
- Reason
- There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
- Classification
- Class II
- Recalling firm
- Surgical Innovations Ltd
- Quantity
- N/A
- Agency-reported status
- Completed
- Source record identifier
- Z-1396-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Lots; UDI/DI:05051986001562 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 Kong, Hungary, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, N. Ireland, Norway, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Dubai.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 27, 2022
- Recall initiation date
- Jun 2, 2022
- Center classification date
- Jul 18, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.