Mani Trocar Kit, Model MTK23S and Model MTK25S recallZ-1468-2023 · Mani, Inc. - Kiyohara Facility · initiated Feb 20, 2023
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mani, Inc. - Kiyohara Facility or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A packaging defect may compromise the sterile barrier.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1468-2023
- Status
- Terminated
- Initiated by the company
- Feb 20, 2023
- Posted by the FDA
- Apr 26, 2023
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Quantity
- 45 kits
- Product code
- NGY
- Distribution
- Distribution in US - 1 consignee in Missouri
Product description
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.
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MANI Trocar Kit MTK25S TROCAR KIT 25G SMani, Inc. · Cannula, trocar, ophthalmic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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