Z-0558-2021Class II

MANI Infusion Cannula 23G S -

Name: Z-0558-2021 MANI Infusion Cannula 23G S -
Creator: Mani, Inc. - Kiyohara Facility
Published: 2020-10-27
License: https://open.fda.gov/license/

Mani, Inc. (Head Office) / initiated 2020-10-27 / Terminated

FDA source

Mani, Inc. - Kiyohara Facility began a recall of MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S on 2020-10-27. FDA classified it as Class II and gives the reason as "Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0558-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-27
Posted: 2020-12-10
Terminated: 2021-08-11
Recalling firm: Mani, Inc. (Head Office)
Product: MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
Product code: NGY Cannula, Trocar, Ophthalmic
Reason for recall: Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
FDA 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 in commerce: 60 units (US)
Distribution: US Nationwide distribution in the state of MO.
Product codes and lots: Lot Codes: V180082900, Exp. Date: 2020/11 and V190000100, Exp Date: 2020/12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0558-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10
Z-0558-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10

Product code NGY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)