FDA Device recall Z-1570-2023
M-Close Kit, REF 27-101
- FDA Device
- Class II
- terminated
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of M-Close Kit, REF 27-101 by New Wave Endo Surgical, citing the plastic housing on the device may fracture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1570-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-08 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | New Wave Endo Surgical |
| Distribution | US |
Product
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Reason
The plastic housing on the device may fracture
Identifiers
| code_info | UDI/DI: 00850009417022, Lot code C2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.