CareFusion Bipolar Surgical Forceps Recalled for Incomplete Instructions
CareFusion bipolar surgical forceps are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.
What this means for you
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 an FDA Class II recall with no reported adverse events or illnesses. The issue is incomplete documentation rather than a device defect itself. Under the rubric, recalls with missing instructions and no reported harm qualify as Moderate severity.
Plain-English summary
CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT are being recalled due to incomplete Instructions for Use (IFU). Specifically, the instructions provided by BD are missing critical content from the manufacturer's IFU related to the device's interface with power supplies and proper cleaning and maintenance procedures.
This recall affects 147 units distributed nationwide and internationally to healthcare facilities in Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. The device reference number is F-5302 with UDI/DI 10885403041273.
Without complete instructions, healthcare providers may not properly interface the device with power supplies or follow correct cleaning and maintenance protocols. BD has determined that this missing information must be provided to ensure safe and proper use of the device.
Healthcare facilities using this product should obtain and review the corrected Instructions for Use from BD, which includes the complete power supply interface and maintenance information.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- improper-maintenance
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 10885403041273
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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