All recalls7,869 total
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Potential Listeria monocytogenes contamination.
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Lack of Assurance of Sterility.
Due to an device without a premarket clearance being incorrectly package and distributed.
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Product may be contaminated with Salmonella
Failed Dissolution Specifications
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Potential for anesthesia leakage.
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Potential for anesthesia leakage.
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Elevated levels of lead in Cinnamon powder.
Undeclared Peanuts. The firm received two complaints that the product contains peanuts which are not listed in the ingredient statement.
Product found to contain leachable lead levels.
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
A potential issue with the seal integrity of header bag packaging.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.