Bipolar Forceps Recall: Missing Device Instructions for Use
Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.
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 a documentation and instructions issue with no reported adverse events. While missing instructions related to power supply interface and maintenance on surgical equipment could pose a risk, FDA Class II recalls involving incomplete documentation without reported illnesses or injuries are classified as Moderate per the severity rubric.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller SEMKIN BIPOLAR FORCEPS with a 1.5mm tip and 6-inch overall length (model F-1045). The original Instructions for Use (IFU) provided with the device contain incomplete information.
The missing content includes instructions related to the device's interface with its power supply and procedures for cleaning and maintenance. These instructions are necessary for the safe operation and proper care of the forceps. Healthcare facilities should discontinue use of the incomplete original IFU.
The recall affects 119 units distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. All lots are included in this recall (UDI/DI 10885403040764).
Affected healthcare providers should immediately switch to the corrected Instructions for Use provided by the manufacturer to ensure proper operation, maintenance, and cleaning of the bipolar forceps.
The recalled product
- Product
- Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- incomplete-instructions
- missing-maintenance-info
- power-supply-interface
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 10885403040764
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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