All recalls7,869 total
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
The impacted lot may not meet the required tensile strength specification.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
The impacted lot may not meet the required tensile strength specification.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
Product may contain Listeria monocytogenes.
Lack of Assurance of Sterility:
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Potential contamination with Listeria monocytogenes.
Contains elevated levels of lead (Pb)
Potential contamination with Listeria monocytogenes
Eggs may be contaminated with Salmonella.
Potential contamination with Listeria monocytogenes.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Organic Spinach has the potential to be contaminated with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
The nasal feeding tube may be occluded
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.