CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Cutting Electrode Bipo recalled by Richard Wolf
Richard Wolf is recalling Cutting Electrode Bipo 24, distributed nationwide in the US. The recall was initiated on 25 Jun 2021 and the FDA has classified it as Class II.
Check your package
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-2246-2021
- FDA event ID
- 88249
- Recalling firm
- Richard Wolf, Knittlingen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2021
- FDA classified
- 11 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2021 | Recall initiated by company | |
| 11 Aug 2021 | Classified by FDA | +47 days |
| 18 Aug 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeled as Cutting Electrode may contain BIVAP electrode.
Product as listed by the FDA
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Where it was distributed
US Nationwide Distribution in the states of CA, CO, IN, MA, NH
Nationwide CaliforniaColoradoIndianaMassachusettsNew Hampshire
Questions about this recall
Why was it recalled?
Product labeled as Cutting Electrode may contain BIVAP electrode.
Which lots are affected?
Lot Number 21002858
Where was it sold?
US Nationwide Distribution in the states of CA, CO, IN, MA, NH
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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