CLASS II Device recall · Reported 17 Jul 2019 · FDA Enforcement Report

E-Line Cutting Electrode Mono 0 degrees, Sterile recalled

Richard Wolf Medical Instruments is recalling E-Line Cutting Electrode Mono 0 degrees, Sterile, distributed nationwide in the US. The recall was initiated on 23 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024

Quantity recalled5 boxes (5 electrodes each)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1957-2019
FDA event ID: 82946
Recalling firm: Richard Wolf Medical Instruments, Vernon Hills, IL
Classification: Class II
Status: Terminated
Recall initiated: 23 May 2019
FDA classified: 10 Jul 2019
Reported: 17 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

23 May 2019	Recall initiated by company
10 Jul 2019	Classified by FDA	+48 days
17 Jul 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Missouri Rhode Island South Carolina

Questions about this recall

Is E-Line Cutting Electrode Mono 0 degrees, Sterile recalled?

Yes. Richard Wolf Medical Instruments recalled E-Line Cutting Electrode Mono 0 degrees, Sterile on 23 May 2019. The recall is Class II and its status is Terminated. Recall number Z-1957-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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