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 24881–24900 of 38,428 recalls
Recalled Item: AMS-636
The Issue: Incorrect priming volume printed on the device package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly Component Trial
The Issue: The dovetails of poly trials, Beta 2.0, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly Component Trial
The Issue: The dovetails of poly trials, Beta 2.0, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly Component Trial
The Issue: The dovetails of poly trials, Beta 2.0, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product
The Issue: Terumo CVS initiated a voluntary recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MaxGuard Extension Set with Injection Site and 0.2 micron filter
The Issue: CareFusion is recalling the MaxGuard Extension Set with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1-Level Sensor II Pads
The Issue: Terumo CVS initiated a voluntary recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MaxGuard Extension Set
The Issue: CareFusion is recalling the MaxGuard Extension Set due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 16 TruePoint - 3R
The Issue: The mobile-specific instructions was not shipped to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 6 TruePoint
The Issue: The mobile-specific instructions was not shipped to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 16 TruePoint TrueV - 4R
The Issue: The mobile-specific instructions was not shipped to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 6 TruePoint
The Issue: The mobile-specific instructions was not shipped to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope...
The Issue: Fujifilm is recalling multiple endoscopes after a retrospective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants Sports Med Repicci II Tibial Components Product
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants Hips Active Articulation ArComXL Bearings...
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants Extremities
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: various polyethylene implants Custom parts Product Usage: Custom
The Issue: Endotoxin levels higher than process maximum limits were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .045 X 6 ST Guide Wire
The Issue: Guide wires sized as .045 X 6 were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.