Class II — Mani, Inc. - Kiyohara Facility
| Recalling firm | MANI, INC. (HEAD OFFICE) |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A packaging defect may compromise the sterile barrier. |
| 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. |
| Quantity | 45 kits |
| Distribution | Distribution in US - 1 consignee in Missouri |
| Initiated | 2023-02-20 |
| Classified | 2023-04-26 |
| Terminated | 2025-05-19 |
| Recall number | Z-1468-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mani, Inc. - Kiyohara Facility (Z-1468-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91829/
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