All recalls7,869 total
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Convenience kits labeled as sterile have not gone through the sterilization process.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Oyster product potentially contaminated with Norovirus
Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.
Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.
Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.
Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
The catheters may not retain their shape.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Allergen labeling: missing allergens (peanuts, milk) in contains statement
Unapproved Drug Claims.
Unapproved Drug Claims.
Allergen labeling: egg is not listed in the 'contains' statement
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Allergen labeling: specific tree nut (pecan) and egg not listed in 'contains' statement
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Allergen labeling: specific tree nut (pecans) not listed in the 'contains' statement
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Allergen labeling: egg not listed in the 'contains' statement
Unapproved Drug Claims.
Allergen labeling: specific tree nut (walnut) and egg are not listed in the 'contains' statement
Allergen labeling: egg is not listed in the 'contains' statement
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Allergen labeling: specific tree nut (pecan) not listed in 'contains' statement
Allergen labeling: specific tree nut (pecan) and egg are not listed in the 'contains' statement
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.