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 7441–7460 of 38,428 recalls
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
The Issue: Recent reports of patient infection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Bronchovideoscope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Airway Mobilescope
The Issue: Complaint of endoscope model becoming lodged in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-MR1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-C1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton C1/T1/MR1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-T1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-T1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-T1
The Issue: Degrading capacitors on the control board of ventilators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/L Taper Hip Prosthesis Extended Offset
The Issue: The outer package labeling and product etch are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare
The Issue: A crack in the weld of the rasp
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Membrane Changer Single-Use
The Issue: During rework of components during the manufacturing process,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVU Functional GI Software
The Issue: GI Software labelled as revision 3.3.0 is incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
The Issue: There is a potential for ADVIA Chemistry Urinary/Cerebrospinal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The O-arm O2 Imaging System is a mobile x-ray system
The Issue: Ground cable installed incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Lead Clipper- An auxiliary tool indicated for use in
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT
The Issue: A complaint was received indicating that a package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.