Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 21761–21780 of 38,428 recalls
Recalled Item: ADVIA Centaur CA 125II Assay
The Issue: Upon dilution, some patient samples may exhibit over-recovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 56% 1 Day Silicone Hydrogel (-4.50)
The Issue: The secondary packaging is labeled with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: clariti 1 day/Fresh Day 90 pack (-1.00)
The Issue: The secondary packaging is labeled with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 56% 1 Day Silicone Hydrogel (-2.50)
The Issue: The secondary packaging is labeled with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic
The Issue: The U.S. Instructions For Use for the Mega
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic
The Issue: The U.S. Instructions For Use for the Mega
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 with 4.1.7 XX026 software version model number 728231
The Issue: Surview scan with tube current lower than 30
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic
The Issue: The U.S. Instructions For Use for the Mega
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Acute Care System (IACS) Monitoring Solution
The Issue: The invasive pressure visual and audible alarms may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: F-T3SYSTEM
The Issue: The recalling firm has become aware that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource PBDS
The Issue: A defect in the seal of the Gatorade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource PBDS
The Issue: A defect in the seal of the Gatorade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource PBDS
The Issue: A defect in the seal of the Gatorade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource PBDS
The Issue: A defect in the seal of the Gatorade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza software VB10A model numbers: 10863171
The Issue: Software upgrade to correct format of study dates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System
The Issue: Software upgrade to correct format of study dates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS T2X Table
The Issue: The rotational locking mechanisms on the ORT 100/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS ORT100 Table
The Issue: The rotational locking mechanisms on the ORT 100/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone
The Issue: Lack of adequate validation and controls to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini
The Issue: Lack of adequate validation and controls to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.