Surgical Innovations Ltd recalls YelloPort Elite Universal Seal. For use in laparoscopic procedures.
- Recall date
- June 2, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1396-2022
- FDA classification
- Class II
- Brand / firm
- Surgical Innovations Ltd
- Sold / 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, M…
Why it was recalled
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
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