Mani, Inc. - Kiyohara Facility: Medical Device Recall in 2023 - (Recall #: Z-1468-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 20, 2023

Date Posted: May 3, 2023

Recall Number: Z-1468-2023

Event ID: 91829

Reason for Recall:

A packaging defect may compromise the sterile barrier.

Status: Terminated

Product Quantity: 45 kits

Code Information:

UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)

Distribution Pattern:

Distribution in US - 1 consignee in Missouri

Voluntary or Mandated:

Voluntary: Firm initiated