Z-0145-2014Class II

Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite...

Name: Z-0145-2014 Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2013-09-18
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2013-09-18 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf Medical Instruments Corp. began a recall of Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous... on 2013-09-18. FDA classified it as Class II and gives the reason as "Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0145-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Posted: 2013-11-04
Terminated: 2017-04-24
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: 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.
Product code: FJL Resectoscope
Reason for recall: Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Richard Wolf, sent an "Urgent: Medical Device Recall" letter dated September 16, 2013, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory of vaporization electrodes from lot 426111, contact Richard Wolf Medical Instrument Corporation at 800-323-9653 x 344 or ext 225 or ext. 380 to inform Richard Wolf Medical Instrument Corporation if the customer has or does not have any devices from this lot, return the affected devices with the return authorization provided by Richard Wolf Medical Instrument Corporation for credit, and complete and return the attached Recall Response form via fax to: 847-913-0924; email: [email protected]; or mailed to: Richard Wolf Medical Instrument Corporation, 353 Corporate Woods Parkway, Vernon Hills, IL 60061-3110. Customers who require urgent replacement of the affected devices can contact their customer service representative for replacement. If you have any questions, call 800-323-9653 x 344.
Quantity in commerce: 78 cartons (234 units)
Distribution: Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.
Product codes and lots: *** 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0145-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0145-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code FJL

K062720Class IIS-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. / cleared 2007-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)