MANI TROCAR KIT 23G S — Class II medical device recall Z-0557-2021
Terminated recall by Mani, Inc. - Kiyohara Facility, reported 2020-12-16, distributed nationwide. Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconn
| Recall number | Z-0557-2021 |
|---|---|
| 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 | 2020-10-27 |
| Classified | 2020-12-10 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2021-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Reason classes | specification failure, packaging |
| Lot numbers | 2020/10, 2022/03, V180077300, V200009500 |
| Model numbers | 23S |
Product
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Reason for recall
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
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-0557-2021. 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.