Medical Device Recall: Missing Instructions for Bipolar Surgical Forceps
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class II device with incomplete Instructions for Use and no reported injuries or illnesses. The recall is due to a documentation issue—missing content about power supply interface and maintenance procedures—rather than a product defect.
Plain-English summary
CareFusion V. Mueller titanium round handle bayonet bipolar forceps (Model F-5018, 1.0mm tip, 10.5 inches overall length) are being recalled nationwide and internationally due to incomplete Instructions for Use (IFU).
The IFU provided by distributor BD is missing content that is contained in the manufacturer's complete instructions. The missing information relates to the interface between the device and its power supply, as well as cleaning and maintenance instructions.
The recall affects 46 units distributed nationwide in the United States, as well as in Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand. All lots are included, identified by UDI/DI 10885403041068.
No injuries or illnesses have been reported. Healthcare providers should reference the complete manufacturer Instructions for Use (provided by CareFusion) when using this device.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- Affected units
- 46
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 10885403041068
- 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.
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