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 32341–32360 of 38,428 recalls
Recalled Item: Tonometers are manual devices intended to measure intraocular pressure by
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cushing burrs are bone cutting and drilling instruments that are
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manual trephines are bone cutting and drilling instruments that are
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson cerebellar extensions are bone cutting and drilling instruments that
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Traction tong replacement screws
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement screw non-springloaded traction tongs are skull tongs for traction
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson braces are bone cutting and drilling instruments that are
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lock nuts for titanium traction tongs are used in traction
The Issue: The reason these devices are being withdrawn from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biatain Super Non-Adhesive
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System (VITROS 5
The Issue: Ortho Clinical Diagnostics (OCD) identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Ortho Clinical Diagnostics (OCD) identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI¿ Pediatric Anesthesia Breathing Circuits
The Issue: The pediatric breathing circuits can crack prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Expression MR200 MRI Patient Monitoring System Model 866120
The Issue: During production, excess metal (aluminum) debris was found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled
The Issue: The software issue described was corrected in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Expression MR200 MRI Patient Monitoring System
The Issue: Failure to produce the Non-Invasive Blood Pressure (NIBP)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 500D
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vantage Panoramic X-Ray System used to perform dental and orthodontic
The Issue: Failure of the primary collimator may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Innova IGS 540 Indicated for use for patients from newborn
The Issue: Loss of imaging - affected devices may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Innova 4100IQ Indicated for use in generating fluoroscopic images of
The Issue: Loss of imaging - affected devices may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery IGS 740 Indicated for use for patients from newborn
The Issue: Loss of imaging - affected devices may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.