# FDA recall Z-1396-2022

> **Surgical Innovations  Ltd** · Class II · device recall initiated 2022-06-02.

## Product

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1396-2022
- **Recalling firm:** Surgical Innovations  Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-06-02
- **Report date:** 2022-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leeds, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2022

## Citation

> AI Analytics. FDA recall Z-1396-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1396-2022. Source: US FDA. Licensed CC0.

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