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 6241–6260 of 38,428 recalls
Recalled Item: BD BBL Sensi Disc Aztreonam - 30 ug¿
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Levofloxacin- 5 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Augmentin - 3¿g
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Ceftazidime- 30 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Ofloxacin- 5 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Cefixime - 5 ug¿
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating
The Issue: Nonconformities at their seal could potentially compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Ampicillin - 10 ¿g
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Cefuroxime- 30 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Ceftriaxone- 30 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating
The Issue: Nonconformities at their seal could potentially compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Doripenem- 15 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Sensi Disc Clarithromycin- 15 ug
The Issue: There is a possibility of reproducibility, accuracy, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemostasis Probe
The Issue: The BICOAG Hemostasis Probe with a coaxial plug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices -
The Issue: OPTIMIZER devices may cease to deliver CCM therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Contro-Bulb Syringe
The Issue: Packaging material was updated for the Bulb Irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
The Issue: A software error caused an increase in tray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USTAR II Knee System Cemented curved stem
The Issue: Their is a potential that the implant curved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.