M-Close Kit — Class II medical device recall Z-1570-2023
Terminated recall by New Wave Endo-Surgical, Corp., reported 2023-05-17, distributed nationwide. The plastic housing on the device may fracture
| Recall number | Z-1570-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Wave Endo-Surgical, Corp., Coconut Creek, FL, United States |
| Recall initiated | 2020-07-08 |
| Classified | 2023-05-09 |
| Reported by FDA | 2023-05-17 |
| Terminated | 2024-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 295 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00850009417022 |
| Lot numbers | C2020 |
| Model numbers | 27-101 |
Product
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Reason for recall
The plastic housing on the device may fracture
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-1570-2023. 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.