# FDA recall Z-0558-2021

> **Mani, Inc. - Kiyohara Facility** · Class II · device recall initiated 2020-10-27.

## Product

MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

## Reason for recall

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

## Distribution

US Nationwide distribution in the state of MO.

## Key facts

- **Recall number:** Z-0558-2021
- **Recalling firm:** Mani, Inc. - Kiyohara Facility
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-27
- **Report date:** 2020-12-16
- **Termination date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Utsunomiya, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0558-2021

## Citation

> AI Analytics. FDA recall Z-0558-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0558-2021. Source: US FDA. Licensed CC0.

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