Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

M-Close Kit Recalled by New Wave Endo-Surgical, Corp. Due to The plastic housing on the device may fracture

Date: July 8, 2020
Company: New Wave Endo-Surgical, Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact New Wave Endo-Surgical, Corp. directly.

Affected Products

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

Quantity: 295 units

Why Was This Recalled?

The plastic housing on the device may fracture

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About New Wave Endo-Surgical, Corp.

New Wave Endo-Surgical, Corp. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report