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 23301–23320 of 38,428 recalls
Recalled Item: Nitinol TC Reusable Electrodes (TCN)
The Issue: After multiple reprocessing cycles, the epoxy resin which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number:...
The Issue: A software malfunction can occur on the cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche / Hitachi MODULAR Analyzer Systems-Immunoassay...
The Issue: A software malfunction can occur on the cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phadia 1000 Instrument
The Issue: The "Retry" command does not function properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Partial Knee System
The Issue: Finishing guide does not adequately account for shape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafetyGlide Needle
The Issue: Centurion is recalling specific lots of convenience kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthofix Power Drill Torque Limiter
The Issue: The power drill torque limiter may break during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product...
The Issue: A small number of batches may crack or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600...
The Issue: Teleflex Medical is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HomeChoice Pro Automated PD system Model numbers: 5C8310
The Issue: Baxter Healthcare Corporation has been made aware that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HomeChoice Automated PD system Model numbers: 5C4471
The Issue: Baxter Healthcare Corporation has been made aware that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur
The Issue: Three (3) complaints were identified in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser UL Station surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser Diode Laser surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser UL C02 Laser surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beijing Syntech Laser Trixel C02 Laser surgical lasers
The Issue: The noncompliance is that the certification label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.