Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mani Trocar Kit Recalled by Mani, Inc. - Kiyohara Facility Due to A packaging defect may compromise the sterile barrier.

Date: February 20, 2023
Company: Mani, Inc. - Kiyohara Facility
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mani, Inc. - Kiyohara Facility directly.

Affected Products

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.

Quantity: 45 kits

Why Was This Recalled?

A packaging defect may compromise the sterile barrier.

Where Was This Sold?

Distribution in US - 1 consignee in Missouri

About Mani, Inc. - Kiyohara Facility

Mani, Inc. - Kiyohara Facility has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report