Z-2246-2021Class II

Cutting Electrode Bipo 24.5Fr, Ref 4653.1323

Name: Z-2246-2021 Cutting Electrode Bipo 24.5Fr, Ref 4653.1323
Creator: Richard Wolf GmbH
Published: 2021-06-25
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2021-06-25 / Terminated / root cause: labeling and UDI

FDA source

Richard Wolf GmbH began a recall of CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 on 2021-06-25. FDA classified it as Class II and gives the reason as "Product labeled as Cutting Electrode may contain BIVAP electrode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2246-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-25
Posted: 2021-08-12
Terminated: 2024-01-05
Recalling firm: Richard Wolf GmbH
Product: Cutting Electrode Bipo 24.5Fr, Ref 4653.1323
Product code: FJL Resectoscope
Reason for recall: Product labeled as Cutting Electrode may contain BIVAP electrode.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device.
Quantity in commerce: 20 boxes
Distribution: US Nationwide Distribution in the states of CA, CO, IN, MA, NH
Product codes and lots: Lot Number 21002858

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2246-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2246-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-11

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)