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 18901–18920 of 38,428 recalls
Recalled Item: 3mL Luer-Lok Syringe
The Issue: The syringes have scale markings that were printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGenTrabecular Metal Tibial Half Block Augment
The Issue: Potentially comingled, resulting in the product in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGenTrabecular Metal Tibial Half Block Augment
The Issue: Potentially comingled, resulting in the product in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Transseptal Needle
The Issue: The products were manufactured without a back bevel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15...
The Issue: Certain LIFEPAK 15 Monitors/ Defibrillators were reported to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15
The Issue: Certain LIFEPAK 15 Monitors/ Defibrillators were reported to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rhondium OVC3 One Visit Crown
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Semi-Rigid Suction Canister
The Issue: for the Semi-Rigid canister lid to fragment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
The Issue: Cepheid Xpert Respiratory Control Panel (Catalog #8199) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Velofix SA cervical cage
The Issue: The vertical dimensions of screw-hole position in some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TASE 400 Imaging systems
The Issue: the Nominal Ocular Hazard Distance (NOHD) associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TASE 500 Imaging systems
The Issue: the Nominal Ocular Hazard Distance (NOHD) associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LivaNova Sorin Connect DPIII KOMPL. S5
The Issue: Incorrect labeling; it was identified that some Datapad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON NX2 Elite Diagnostic Ultrasound System
The Issue: The action is being initiated due to internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON NX3 Diagnostic Ultrasound System
The Issue: The action is being initiated due to internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON NX3 Elite Diagnostic Ultrasound System
The Issue: The action is being initiated due to internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON NX2 Diagnostic Ultrasound System
The Issue: The action is being initiated due to internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Smart Disclosure System
The Issue: Several reports were received that patient records were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.