Class II — Surgical Innovations Ltd
| Recalling firm | SURGICAL INNOVATIONS PLC |
|---|---|
| Registered facility | SURGICAL INNOVATIONS LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. |
| Product | YelloPort Elite Universal Seal. For use in laparoscopic procedures. |
| Quantity | N/A |
| 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, Sw… |
| Initiated | 2022-06-02 |
| Classified | 2022-07-18 |
| Recall number | Z-1396-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Surgical Innovations Ltd (Z-1396-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90447/
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