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.

38,428 total recalls
0 this month

Showing 13241–13260 of 38,428 recalls

January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· Medline Industries Inc

Recalled Item: S-O303000 CONTROL

The Issue: Medline Industries, Inc. is removing specific lots of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskTerminated
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· Medtronic Vascular

Recalled Item: Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

The Issue: Sterility may be compromised due to an unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
January 15, 2021· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: CervAlign Anterior Cervical Plate System-Cervalign

The Issue: Locking mechanism has been observed to disassociate either

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing