Medical DeviceMay 3, 2023
Mani, Inc. - Kiyohara Facility Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 recall — FDA Z-1468-2023
A packaging defect may compromise the sterile barrier.
Class IIFDA: TerminatedMani, Inc. - Kiyohara Facility
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceDec 16, 2020
Mani, Inc. - Kiyohara Facility MANI Infusion Cannula 23G S - Product Usage: for use in recall — FDA Z-0558-2021
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Class IIFDA: TerminatedMani, Inc. - Kiyohara Facility
Medical DeviceDec 16, 2020
Mani, Inc. - Kiyohara Facility MANI TROCAR KIT 23G S - Product Usage: for use in injecting recall — FDA Z-0557-2021
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Class IIFDA: TerminatedMani, Inc. - Kiyohara Facility
Understanding this recall history
This page summarizes recall records in which the official source identifies Mani, Inc. - Kiyohara Facility as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.