All recalls8,506 total
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Undeclared Yellow 5, Yellow 6
Subpotent drug; Clavulanate Potassium component
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Undeclared allergen - milk
Undeclared allergen - milk
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lack of Assurance of Sterility.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Presence of Particulate Matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.