Z-1468-2023Class II

Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit...

Name: Z-1468-2023 Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit...
Creator: Mani, Inc. - Kiyohara Facility
Published: 2023-02-20
License: https://open.fda.gov/license/

Mani, Inc. (Head Office) / initiated 2023-02-20 / Terminated / root cause: manufacturing process

FDA source

Mani, Inc. - Kiyohara Facility began a recall of 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... on 2023-02-20. FDA classified it as Class II and gives the reason as "A packaging defect may compromise the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1468-2023
Classification: Class II
Status: Terminated
Initiated: 2023-02-20
Posted: 2023-04-26
Terminated: 2025-05-19
Recalling firm: Mani, Inc. (Head Office)
Product: 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.
Product code: NGY Cannula, Trocar, Ophthalmic
Reason for recall: A packaging defect may compromise the sterile barrier.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm.
Quantity in commerce: 45 kits
Distribution: Distribution in US - 1 consignee in Missouri
Product codes and lots: UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1468-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1468-2023	Class II	Terminated	Voluntary: Firm initiated	2023-05-03	2023-04-26

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)