Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan
Lot Codes / Batch Numbers
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)
Products Sold
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)
Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan is recalling Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 due to A packaging defect may compromise the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A packaging defect may compromise the sterile barrier.
Recommended Action
Per FDA guidance
Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MO
Page updated: Jan 10, 2026