Class II — New Wave Endo-Surgical, Corp.
| Recalling firm | New Wave Endo |
|---|---|
| Registered facility | NEW WAVE ENDO (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The plastic housing on the device may fracture |
| Product | M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall |
| Quantity | 295 units |
| Distribution | US Nationwide distribution in the states of FL, MA, and GA. |
| Initiated | 2020-07-08 |
| Classified | 2023-05-09 |
| Terminated | 2024-07-02 |
| Recall number | Z-1570-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — New Wave Endo-Surgical, Corp. (Z-1570-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92005/
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