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 23521–23540 of 38,428 recalls
Recalled Item: PALLAS M/MAXIMIS Body Alignment Driver. 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 40mm Rod. 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 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 MIS Screw 6.5 x 40mm 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 5.5 x 35mm Curved Rod. 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 50mm Curved and precontoured Rod. 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 Guide Wire. 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 MIS Screw 7.5 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 Distractor. 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 MIS Pedicle Cut. 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 Poly Screw 6.5 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 Poly Screw 6.5 x 35mm. 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 C. 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.
Recalled Item: PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. 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 Poly Screw Driver B. 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. 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 55mm 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 60mm Curved 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 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 Poly Screw 6.5 x 45mm. Part of MAXIMIS
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.