# FDA recall Z-1468-2023

> **Mani, Inc. - Kiyohara Facility** · Class II · device recall initiated 2023-02-20.

## Product

Mani Trocar Kit, Model MTK23S and Model MTK25S    There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

## Reason for recall

A packaging defect may compromise the sterile barrier.

## Distribution

Distribution in US - 1 consignee in Missouri

## Key facts

- **Recall number:** Z-1468-2023
- **Recalling firm:** Mani, Inc. - Kiyohara Facility
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2023-02-20
- **Report date:** 2023-05-03
- **Termination date:** 2025-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Utsunomiya, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2023

## Citation

> AI Analytics. FDA recall Z-1468-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1468-2023. Source: US FDA. Licensed CC0.

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