All recalls8,501 total
Contains undeclared egg, soy, and hazelnut
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Includes an incorrect screw seat interface.
Includes an incorrect screw seat interface.
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Product may contain foreign objects, specifically glass.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Undeclared allergen (almond).
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Neutralization Buffer may contain contaminants
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
May be temperature abused, which may result in growth of Clostridium botulinum
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Lack of Assurance of Sterility
Potential for mislabeled syringe produced by the i.v.STATION device.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Resorbable bone void filler falls outside standard specifications.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Resorbable bone void filler falls outside standard specifications.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.