Bipolar Forceps Recall: Missing Device Use and Maintenance Instructions
CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.
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 recall involving incomplete Instructions for Use for a surgical device. The missing documentation covers critical use procedures (power supply interface) and maintenance instructions, creating potential risk of improper operation. No injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CareFusion 2200 Inc is recalling the V. Mueller Titanium Round Handle Bayonet Bipolar Forceps (Model F-5016, UDI/DI 10885403041051) nationwide and internationally. The Instructions for Use provided by the manufacturer are incomplete and missing critical information related to the device's power supply interface and cleaning and maintenance procedures.
The missing documentation may prevent users from properly understanding how to operate the device safely and maintain it according to manufacturer specifications. Affected units were distributed nationwide and in Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
Healthcare facilities and users of this device should refer to the corrected V. Mueller Bipolar Forceps Instructions for Use, which contains the complete information on power supply interface and cleaning and maintenance instructions. No injuries or adverse events have been reported to date.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
- Manufacturer
- Carefusion 2200 Inc
- 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 10885403041051
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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