Bipolar forceps Instructions for Use missing power supply and maintenance information
CareFusion bipolar forceps have incomplete Instructions for Use missing power supply interface and maintenance guidance. Users should obtain complete instructions from the manufacturer before use.
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: FDA Class II medical device with incomplete Instructions for Use regarding critical operational information (power supply interface and maintenance procedures) with no reported injuries or illnesses, meeting the criteria for risk-of-harm products where injury has not been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has determined that CareFusion 2200 Inc's V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS (Model F-5067, 0.7MM tip, 10-1/2 inches in length) has incomplete Instructions for Use (IFU). The manufacturer's complete IFU contains important information that was not included in the IFU distributed by CareFusion.
The missing content relates to two critical operational areas: the interface between the forceps and the device power supply, and detailed cleaning and maintenance instructions. This incomplete guidance could impact proper use and maintenance of the device.
The affected product was distributed nationwide in the United States and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. All lots produced (UDI/DI 10885403041167) are included in this recall.
No illnesses or injuries have been reported. Users should immediately obtain complete Instructions for Use from CareFusion 2200 Inc before continued use of the device.
The recalled product
- Product
- CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067
- Manufacturer
- Carefusion 2200 Inc
- Category
- Medical Device
- Hazard
- incomplete-instructions
- missing-maintenance-guidance
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 10885403041167
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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