The Recall Desk
HighFDA (Devices)·Z-2246-2021·Announced 2021-08-18

Mislabeled Cutting Electrode May Contain Wrong Electrode Type

Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a product-identity and labeling error with no reported injuries or illnesses. However, the mislabeling creates a risk of harm—using the wrong electrode type in surgery could lead to improper surgical outcomes or patient injury. This fits the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Richard Wolf is recalling certain units of the Cutting Electrode Bipo 24.5FR (REF 4653.1323) because the product may be mislabeled. Specifically, units labeled as Cutting Electrode may actually contain a BIVAP electrode—a different type of surgical electrode.

Using the wrong electrode type during a surgical procedure could create patient safety risks, as the electrodes have different performance characteristics and may not function as intended for the procedure being performed.

The affected product is lot number 21002858 (20 boxes total), which was distributed nationwide to healthcare facilities in California, Colorado, Indiana, Massachusetts, and New Hampshire.

Healthcare providers who have received this product should check their inventory against the lot number. Any units matching lot 21002858 should not be used. Affected healthcare facilities should contact their product distributor or Richard Wolf GmbH to arrange for replacement or return.

The recalled product

Product
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Manufacturer
Richard Wolf GmbH
Category
Medical Device — Surgical / Electrosurgical Equipment
Hazard
  • mis-labeling
  • electrode-type-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 21002858

Distribution

Distributed nationwide across the United States.

Related recalls

Same category