All recalls7,869 total
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
Product label includes the ingredient CREAM but does not include Milk as the source.
Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Undeclared sesame.
Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Gelson branded Tzatziki sauce product labels do not include storage instructions "keep refrigerated"
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
Product label includes the ingredient CREAM but does not include Milk as the source.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Undeclared wheat and milk from sub-ingredients.
Undeclared milk and soy (from soy lecithin) from sub-ingredients.
Undeclared milk and/or eggs from sub-ingredients and/or Contains statement.
foreign material (plastic)
Undeclared wheat, milk, and soy (from soy lecithin) from sub-ingredients.
Undeclared milk from Contains statement.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Under-processed product may contain pathogenic bacteria that could harm to humans.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.