💊 Drugs Class I - Dangerous
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
All Recalls
92,900 total recalls in our database
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Aspen Biopharma Labs Pvt.
💊 Drugs Class I - Dangerous
CGMP Deviations
🏥 Medical Devices Class I - Dangerous
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
🏥 Medical Devices Class I - Dangerous
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).
🏥 Medical Devices Class I - Dangerous
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
🏥 Medical Devices Class I - Dangerous
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).
🏥 Medical Devices Class I - Dangerous
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
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
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Philips Medical Systems Nederland B.V.
🏥 Medical Devices Class I - Dangerous
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).
🏥 Medical Devices Class I - Dangerous
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).
🏥 Medical Devices Class I - Dangerous
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.
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
🏥 Medical Devices Class I - Dangerous
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.