CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
YelloPort Elite Universal Seal recalled by Surgical Innovations
Surgical Innovations is recalling YelloPort Elite Universal Seal, distributed nationwide in the US. The recall was initiated on 2 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1396-2022
- FDA event ID
- 90447
- Recalling firm
- Surgical Innovations, Leeds, N/A
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Jun 2022
- FDA classified
- 18 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 2 Jun 2022 | Recall initiated by company | |
| 18 Jul 2022 | Classified by FDA | +46 days |
| 27 Jul 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Which lots are affected?
All Lots; UDI/DI:05051986001562
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Surgical Innovations
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | YelloPort Elite recalled by Surgical Innovations | Surgical Innovations | Sterility | MA |
| Device | CLASS II | YelloPort Elite recalled by Surgical Innovations | Surgical Innovations | Sterility | MA |
| Device | CLASS II | Product/Part: YelloPort Elite Pencil Point Trocar/ET1207503 recalled | Surgical Innovations | Sterility | MA |
| Device | CLASS II | Product/Part: YelloPort Plus Cannula + Luer/YC0507001 recalled | Surgical Innovations | Sterility | MA |
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