# FDA recall Z-1601-2023

> **Surgical Innovations Ltd** · Class II · device recall initiated 2023-03-28.

## Product

YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

## Reason for recall

Optical Trocars sterility assurance can not be guaranteed

## Distribution

US: MA OUS: None

## Key facts

- **Recall number:** Z-1601-2023
- **Recalling firm:** Surgical Innovations Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-28
- **Report date:** 2023-05-24

- **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-1601-2023

## Citation

> AI Analytics. FDA recall Z-1601-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1601-2023. Source: US FDA. Licensed CC0.

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