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Unrated Medical device recall · FDA · Published June 25, 2021

Richard Wolf Cutting Electrode BIPO 24.5FR Recall: BIVAP Electrode Hazard

Richard Wolf recalls Cutting Electrode BIPO 24.5FR model 4653.1323 with BIVAP electrode risk. Affected units sold in 2021; stop using immediately.

🇺🇸 FDA recall #Z-2246-2021Medical deviceRichard Wolf ›
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Contact the company

Recalling firmRichard Wolf GmbHPforzheimer Str. 32 · Knittlingen, Germany
✎ GovInfoNow plain-language explainer

Richard Wolf is recalling a specific cutting electrode model due to a potential BIVAP electrode mix-up. This could cause safety issues if the wrong electrode is used in medical procedures. Read more at govinfonow.com/recall/62303-richard-wolf-cutting-electrode-bipo-24-5fr-recall-bivap-electrode.

Source Summary by GovInfoNow · govinfonow.com/recall/62303-richard-wolf-cutting-electrode-bipo-24-5fr-recall-bivap-electrode · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2246-2021

Cite this page

“Richard Wolf Cutting Electrode BIPO 24.5FR Recall: BIVAP Electrode Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62303-richard-wolf-cutting-electrode-bipo-24-5fr-recall-bivap-electrode. Based on FDA recall #Z-2246-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2246-2021%22&limit=1).

The FDA announced on June 25, 2021, that Richard Wolf GmbH voluntarily recalled CUTTING ELECTRODE BIPO 24.5FR units because they may contain a BIVAP electrode instead of the labeled cutting electrode.

How to tell if you have it

  • Brand: Richard Wolf
  • Product: CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
  • Lot Number: 21002858

The hazard

The product labeled as a Cutting Electrode may contain a BIVAP electrode, according to the FDA.

Context

GovInfoNow's records show Richard Wolf GmbH has 6 other recalls on record since July 24, 2017. Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), Wilson-Cook Teslatome Sphincterotomes Recall (December 18, 2025), and Olymp BiCOAG Hemostasis Probe 7Fr Connector Recall (August 19, 2026).

How to tell if you have this one

Check for the model number 4653.1323 on the Cutting Electrode BIPO 24.5FR. Units were sold with lot number 21002858 in 2021.

  • Brand
    Richard Wolf
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    The recalled product may contain a BIVAP electrode that could cause safety issues during medical procedures.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide Distribution in the states of CA, CO, IN, MA, NH” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Indiana, Massachusetts, New Hampshire.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Jun 25, 202112. FDA classified it Class II: Aug 11, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Jan 5, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2246-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2246-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA