Z-1570-2023Class II

M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the...

Name: Z-1570-2023 M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the...
Creator: New Wave Endo-Surgical, Corp.
Published: 2020-07-08
License: https://open.fda.gov/license/

New Wave Endo / initiated 2020-07-08 / Terminated

FDA source

New Wave Endo-Surgical, Corp. began a recall of M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall on 2020-07-08. FDA classified it as Class II and gives the reason as "The plastic housing on the device may fracture". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1570-2023
Classification: Class II
Status: Terminated
Initiated: 2020-07-08
Posted: 2023-05-09
Terminated: 2024-07-02
Recalling firm: New Wave Endo
Product: M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Product code: HCF Instrument, Ligature Passing And Knot Tying
Reason for recall: The plastic housing on the device may fracture
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 295 units
Distribution: US Nationwide distribution in the states of FL, MA, and GA.
Product codes and lots: UDI/DI: 00850009417022, Lot code C2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1570-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1570-2023	Class II	Terminated	Voluntary: Firm initiated	2023-05-17	2023-05-09

Product code HCF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)