CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Individual units labeled in part recalled by Richard Wolf Medical

Richard Wolf Medical Instruments is recalling Individual units labeled in part, distributed nationwide in the US. The recall was initiated on 18 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes*** Individual Units *** Product Code: 4630022 (single); Lot: 426111; Expiration Date: 2016/06; *** Cartons *** Product Code: 46300223 (box of 3); Lot: 426111; Expiration Date: 2016/06;

Quantity recalled78 cartons (234 units)

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-0145-2014
FDA event ID: 66457
Recalling firm: Richard Wolf Medical Instruments, Vernon Hills, IL
Classification: Class II
Status: Terminated
Recall initiated: 18 Sep 2013
FDA classified: 4 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

18 Sep 2013	Recall initiated by company
4 Nov 2013	Classified by FDA	+47 days
13 Nov 2013	Published in enforcement report	+9 days

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

Reason for recall

Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.

Where it was distributed

Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.

Nationwide California Georgia Illinois Kentucky Louisiana Maryland Michigan New York Oregon Puerto Rico Texas Virginia

Questions about this recall

Is Individual units labeled in part recalled?

Yes. Richard Wolf Medical Instruments recalled Individual units labeled in part on 18 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0145-2014.

Why was it recalled?

Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

Which lots are affected?

*** Individual Units *** Product Code: 4630022 (single); Lot: 426111; Expiration Date: 2016/06; *** Cartons *** Product Code: 46300223 (box of 3); Lot: 426111; Expiration Date: 2016/06;

Where was it sold?

Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.

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.

More recalls from Richard Wolf Medical Instruments

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17 Jul 2019Device	CLASS II	E-Line Cutting Electrode Mono 0 degrees, Sterile recalled	Richard Wolf Medical Instruments	Foreign Material	Nationwide
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23 Mar 2016Device	CLASS II	The Vesa 75/100 adaptation with rotation is an accessory to recalled	Richard Wolf Medical Instruments	Other	Nationwide
17 Feb 2016Device	CLASS II	Reuseable rotary blade/abrader, product number recalled	Richard Wolf Medical Instruments	Foreign Material	WA
17 Feb 2016Device	CLASS II	Reuseable rotary blade/abrader, product number recalled	Richard Wolf Medical Instruments	Foreign Material	WA

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