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 17121–17140 of 38,428 recalls
Recalled Item: SOMATOM go.All
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Medical X-ray Imaging System
The Issue: X-ray imaging system positioning image and protocol label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiForce GX560 monochrome LCD monitor
The Issue: Under certain conditions, a marble pattern infrequently appears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiForce RX360
The Issue: Under certain conditions, a marble pattern infrequently appears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000
The Issue: Atellica CH 930 Analyzer - Erroneous Indices for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan/CF: a) 3.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan/HVT: a) 5.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan Preformed: a) 3.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan Uncuffed: a) 2.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan LTS: a) 4.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/HVT Novaplus: a) 7.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/CF Novaplus 7.0 mm
The Issue: Reported complaints indicate an increased incidence of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System
The Issue: Artis zee/Q systems patient tables may potentially have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Body Weight Support (BWS) Light
The Issue: The firm discovered a potential manufacturing deviation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTILITE IgM Kit
The Issue: There is a potential that users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Pump I.V. Administration
The Issue: for fluid leakage out of air vents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Pump I.V. Administration
The Issue: for fluid leakage out of air vents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Pump I.V. Administration
The Issue: for fluid leakage out of air vents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Pump I.V. Administration
The Issue: for fluid leakage out of air vents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.