Official product recall notices and clearly labeled enforcement reference records.
Reference notice · drug
Lack of Assurance of Sterility
Dupo, IL, US · Event · Updated
Source: FDA — drug enforcement referenceReference notice · drug
Lack of Assurance of Sterility
Tarrytown, NY, US · Event · Updated
Source: FDA — drug enforcement referenceReference notice · food
Product may contain foreign material: small stones and other hard objects.
Louisville, CO, US · Event · Updated
Source: FDA — food enforcement referenceReference notice · drug
Lack of Assurance of Sterility
Dupo, IL, US · Event · Updated
Source: FDA — drug enforcement referenceReference notice · food
Potential Wheat Kernel contamination.
Minneapolis, MN, US · Event · Updated
Source: FDA — food enforcement referenceReference notice · food
Contamination with Listeria monocytogenes
New York, NY, US · Event · Updated
Source: FDA — food enforcement referenceReference notice · food
Potential Wheat Kernel contamination.
Minneapolis, MN, US · Event · Updated
Source: FDA — food enforcement referenceReference notice · drug
Defective Delivery System: Possibility of no medication in the prefilled pen.
Brookhaven, NY, US · Event · Updated
Source: FDA — drug enforcement referenceReference notice · drug
Lack of Assurance of Sterility
Dupo, IL, US · Event · Updated
Source: FDA — drug enforcement referenceReference notice · food
Potential contamination with pesticides.
San Francisco, CA, US · Event · Updated
Source: FDA — food enforcement referenceReference notice · device
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
Center Valley, PA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycard…
Sandpoint, ID, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
Grove City, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Waukegan, IL, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Shanghai, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
San Diego, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Sittingbourne, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for monomer liquid leakage.
Wehrheim, US · Event · Updated
Source: FDA — device enforcement referenceReport a correction · Related news · Fire information · Clips
