The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0398-2023·Announced 2022-12-14

CareFusion Bipolar Surgical Forceps Recalled by FDA Class II Voluntary Action

CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 units distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary, firm-initiated FDA Class II device recall with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (Score 2).

Plain-English summary

CareFusion 2200 Inc has initiated a voluntary recall of titanium round-handle bayonet bipolar forceps (Reference F-5008) with UDI/DI 10885403041013. The recall encompasses all lots of this product.

The recalled product consists of 4 units that have been distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.

The specific reason for the recall was not disclosed in publicly available information. Healthcare facilities and surgical centers using this instrument should contact CareFusion 2200 Inc to determine if they have received affected units and to arrange for return or replacement.

The recalled product

Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4

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 (2)

  • UDI/DI 10885403041013
  • ALL LOTS

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 45 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 45 products in this recall →

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