FDA Medical Device Recalls (openFDA)
Mani, Inc. - Kiyohara Facility: MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
- Recall number
- Z-0558-2021
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Product
- MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
- Status
- Terminated
- Initiated
- 2020-10-27
- Posted
- not on file
- Terminated
- 2021-08-11
- Reason
- Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
- Root cause
- Unknown/Undetermined by firm
- Action
- MANI Inc. issued Voluntary Removal letter issued on 10/27/20 via email to the US Distributor stating reason for removal, health risk and action to take: request distributors to return the devices. If there are MANI TROCAR KIT and MANI INFUSION CANNULA in your stock and/or your customer's stock: Please write the returning Q'ty. in the list ,"Returned" If MANI TROCAR KIT and MANI INFUSION CANNULA are already used up : Please write the used Q'ty. in the list , "Used. Please send this sheet and relevant items if you have to our address below. Any costs/fees related to this return shipment should be charged to MANI FedEx account. MANI, INC. 8-3, Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231, Japan
- Quantity
- 60 units (US)
- Distribution
- US Nationwide distribution in the state of MO.
- Lot, serial or model codes
- Lot Codes: V180082900, Exp. Date: 2020/11 and V190000100, Exp Date: 2020/12
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NGY
- Firm FEI
- 3002692886
- Firm city
- Utsunomiya
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28