Mani, Inc. - Kiyohara Facility recalls

Mani, Inc. - Kiyohara Facility has 3 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 3 May 2023. The most frequent reason is potency & assay.

Total recalls3since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 May 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why mani, inc. - kiyohara facility is recalled

Potency & Assay267%
Sterility133%

Product types

Heart & Vascular Devices267%
Surgical Instruments133%

By year

2023133%
2020267%

All mani, inc. - kiyohara facility recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
3 May 2023Device	CLASS II	Mani Trocar Kit recalled by Mani, Inc. - Kiyohara Facility	Mani, Inc. - Kiyohara Facility	Sterility	MO
16 Dec 2020Device	CLASS II	Mani Trocar Kit S recalled by Mani, Inc. - Kiyohara Facility	Mani, Inc. - Kiyohara Facility	Potency & Assay	Nationwide
16 Dec 2020Device	CLASS II	MANI Infusion Cannula S recalled by Mani, Inc. - Kiyohara Facility	Mani, Inc. - Kiyohara Facility	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.