# FDA recall Z-2246-2021

> **Richard Wolf GmbH** · Class II · device recall initiated 2021-06-25.

## Product

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

## Reason for recall

Product labeled as Cutting Electrode may contain BIVAP electrode.

## Distribution

US Nationwide Distribution in the states of  CA, CO, IN, MA, NH

## Key facts

- **Recall number:** Z-2246-2021
- **Recalling firm:** Richard Wolf GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-25
- **Report date:** 2021-08-18
- **Termination date:** 2024-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Knittlingen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2246-2021

## Citation

> AI Analytics. FDA recall Z-2246-2021. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-2246-2021. Source: US FDA. Licensed CC0.

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