Bipolar Surgical Forceps Recalled Due to Missing Instructions for Use
CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to power supply interface and cleaning/maintenance procedures.
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 3/5 (High).
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: This is a Class II FDA medical device recall involving missing operational and cleaning instructions for a surgical instrument. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
CareFusion 2200 Inc is recalling the V. Mueller Neuro/Spine titanium bayonet insulated irrigating bipolar forceps, model F-5304. This surgical instrument was distributed nationwide and to multiple countries including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, and Thailand.
The recall was initiated because the originally provided Instructions for Use (IFU) contained missing information. Specifically, the IFU did not include content relating to the interface between the device and its power supply, nor did it contain the required cleaning and maintenance instructions.
The manufacturer has provided a corrected and complete V. Mueller Bipolar Forcep IFU. Healthcare facilities and medical professionals who have received this device should obtain and review the complete instructions before continued use.
The recalled product
- Product
- CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- Affected units
- 18
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 10885403041297
- 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.
See all 45 products in this recall →Related recalls
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · incomplete instructions
See all →- ModeratebkSpecto ultrasound systems recalled over battery guidance gaps in manuals
FDA (Devices) · 2025-11-12
- Moderatebk3000 ultrasound systems recalled over incomplete battery replacement guidance
FDA (Devices) · 2025-11-12
- ModeratebkActiv ultrasound systems recalled over battery guidance missing from manuals
FDA (Devices) · 2025-11-12
- ModerateUltrasound systems recalled over battery guidance missing from the manuals
FDA (Devices) · 2025-11-12
- Moderatebk3500 ultrasound systems recalled over incomplete battery safety instructions
FDA (Devices) · 2025-11-12
Similar recalls
- ModerateStingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions
FDA (Devices) · 2012-07-25
- ModerateIntuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8MM Micro Bipolar Forceps Due to Frayed Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables
FDA (Devices) · 2025-01-22
- ModerateIntuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntegra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect
FDA (Devices) · 2019-08-14