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 | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| Product | MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S |
| Quantity | 60 units (US) |
| Distribution | US Nationwide distribution in the state of MO. |
| Initiated | 2020-10-27 |
| Classified | 2020-12-10 |
| Terminated | 2021-08-11 |
| Recall number | Z-0558-2021 |
| 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-0558-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86873/
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