95,025 total recalls in our database
Heritage Pharmaceuticals
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
Geistlich Pharma North America
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
Coloplast Manufacturing US
Potential increased occurrence of pump fracture over the lifetime of the device.
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Incorrect hip components were provided in kits.
Under certain conditions, there is a risk for fire.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.