Class II — Potential Health Hazard

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

DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a Recalled by Dufner Instrumente GmbH Due to Tungsten carbide plate, which is intended to hold...

Date: June 3, 2020
Company: Dufner Instrumente GmbH
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 Dufner Instrumente GmbH directly.

Affected Products

DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23

Quantity: 30 units

Why Was This Recalled?

Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Dufner Instrumente GmbH

Dufner Instrumente GmbH has 1 total recall tracked by RecallDetector.

Related Recalls

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