Class I - Dangerous
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Potential for intraoperative screw head separation at weld location.
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Class I - Dangerous
This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Philips North America
Class I - Dangerous
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Philips North America
Class I - Dangerous
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Class I - Dangerous
This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.
CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Philips Upgrade to MR 7700 System, Model Number 782130
Philips North America
Class I - Dangerous
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Class I - Dangerous
Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Class I - Dangerous
The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.