M-Close Kit, REF 27-101 recallZ-1570-2023 · New Wave Endo-Surgical, Corp. · initiated Jul 8, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from New Wave Endo-Surgical, Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The plastic housing on the device may fracture
FDA root cause category: Under Investigation by firm
What the company is doing
New Wave Endo issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION to its consignees by email on 07/08/2020. The notice explained the problem with the device and requested the consignee quarantine the device and respond using the recall acknowledgement form. The units were returned and replaced.
Recall details
- Recall number
- Z-1570-2023
- Status
- Terminated
- Initiated by the company
- Jul 8, 2020
- Posted by the FDA
- May 9, 2023
- Recalling firm
- New Wave Endo-Surgical, Corp.
- Quantity
- 295 units
- Product code
- HCF
- Distribution
- US Nationwide distribution in the states of FL, MA, and GA.
Product description
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Code information (models, lots, serial numbers)
UDI/DI: 00850009417022, Lot code C2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- M-Close Kit 27-101New Wave Endo-Surgery Inc. · Instrument, Ligature Passing And Knot Tying1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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