Mani Trocar Kit — Class II medical device recall Z-1468-2023
Terminated recall by Mani, Inc. - Kiyohara Facility, reported 2023-05-03, distributed in MO. A packaging defect may compromise the sterile barrier.
| Recall number | Z-1468-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mani, Inc. - Kiyohara Facility, Utsunomiya, N/A, Japan |
| Recall initiated | 2023-02-20 |
| Classified | 2023-04-26 |
| Reported by FDA | 2023-05-03 |
| Terminated | 2025-05-19 |
| Distributed | MO |
| Quantity | 45 kits |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 14546951403956 |
| Lot numbers | V210006701, V210009101, V210009900, V210028903, V220016001 |
| Model numbers | MTK23S, MTK25S |
| Expiration dates | 2024-11-08 |
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.
Reason for recall
A packaging defect may compromise the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1468-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.