Class II — Potential Health Hazard

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

E-Line Cutting Electrode 11.5Fr Mono 0 degrees Recalled by Richard Wolf Medical Instruments Corp. Due to E-Line Cutting Electrode package 8416.0305 contains E-Line Hook...

Date: May 23, 2019
Company: Richard Wolf Medical Instruments 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 Richard Wolf Medical Instruments Corp. directly.

Affected Products

E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

Quantity: 5 boxes (5 electrodes each)

Why Was This Recalled?

E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Richard Wolf Medical Instruments Corp.

Richard Wolf Medical Instruments Corp. has 9 total recalls tracked by RecallDetector.

Related Recalls

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