95,102 total recalls in our database
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Chemical Contamination
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Aspen Biopharma Labs Pvt.
CGMP Deviations
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Beckman Coulter
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Philips Medical Systems Nederland B.V.
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Catheter manufactured at the incorrect length.
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.