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 13541–13560 of 38,428 recalls
Recalled Item: BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.)
The Issue: BD was advised by the European Notified Body,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex Loss of Resistance Device
The Issue: The labeling was missing information on sterilization and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization...
The Issue: System table may tilt because the bolts that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization...
The Issue: System table may tilt because the bolts that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization...
The Issue: System table may tilt because the bolts that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
The Issue: After the user selects the Lock-in command, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurosign 100
The Issue: A small number of Neurosign 100 Intraoperative Nerve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC-107: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC/ID-108: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC-108: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix" PMIC-109: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Ares Antibiotic-Impregnated Catheter
The Issue: There is a potential for a defect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Ares Antibiotic-Impregnated Catheter
The Issue: There is a potential for a defect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Ares Antibiotic-Impregnated Catheter
The Issue: There is a potential for a defect on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC/ID-105: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC/ID-109: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC/ID-107: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche cobas pro integrated solutions (cobas pro ISE
The Issue: for Changed Configuration Settings on the cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC-110: IVD is intended for the in vitro
The Issue: BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche cobas 8000 modular analyzer series (i.e.
The Issue: for Changed Configuration Settings on the cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.