FDA Medical Device Recalls (openFDA)
New Wave Endo-Surgical, Corp.: M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
- Recall number
- Z-1570-2023
- Recalling firm
- New Wave Endo-Surgical, Corp.
- Product
- M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
- Status
- Terminated
- Initiated
- 2020-07-08
- Posted
- 2023-05-09
- Terminated
- 2024-07-02
- Reason
- The plastic housing on the device may fracture
- 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
- 295 units
- Distribution
- US Nationwide distribution in the states of FL, MA, and GA.
- Lot, serial or model codes
- UDI/DI: 00850009417022, Lot code C2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HCF
- Firm FEI
- 3015209038
- Firm city
- Coconut Creek
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28