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 23641–23660 of 38,428 recalls
Recalled Item: PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0.
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.