Richard Wolf Medical Instruments Corp.: Medical Device Recall in 2019 - (Recall #: Z-1957-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 23, 2019

Date Posted: July 17, 2019

Recall Number: Z-1957-2019

Event ID: 82946

Reason for Recall:

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

Status: Terminated

Product Quantity: 5 boxes (5 electrodes each)

Code Information:

Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024

Distribution Pattern:

US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated