Data Foundry

Medical device recalls 2013

Individual units labeled in part: REF: 4630022 — Class II medical device recall Z-0145-2014

Terminated recall by Richard Wolf Medical Instruments Corp., reported 2013-11-13, distributed nationwide. Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode

Recall numberZ-0145-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmRichard Wolf Medical Instruments Corp., Vernon Hills, IL, United States
Recall initiated2013-09-18
Classified2013-11-04
Reported by FDA2013-11-13
Terminated2017-04-24
DistributedNationwide (US)
Lot numbers2011/06, 2016/06, 426111
Model numbers4630022, 46300223

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0145-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.