Utsunomiya, N/A, Japan
Mani, Inc. - Kiyohara Facility recalls
2 recalls recorded since 2018, most recently on 20 February 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 February 2023
- Terminated
- 19 May 2025
- Reason
- A packaging defect may compromise the sterile barrier.
- Distribution
- Distribution in US - 1 consignee in Missouri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1468-2023
- 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.
Terminated Class II Medical devices
- Recall started
- 27 October 2020
- Terminated
- 11 August 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0558-2021, Z-0557-2021
- MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
- MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.