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 4681–4700 of 38,428 recalls
Recalled Item: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product
The Issue: To limit the use of the Mega Soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name:
The Issue: To limit the use of the Mega Soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode
The Issue: To limit the use of the Mega Soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity hq Analyzer
The Issue: 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discrete photometric chemistry analyzer for clinical use.
The Issue: Beckman Coulter, Inc. has identified a rise in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L-CATH PICC S/L Peripherally Inserted Central Catheter
The Issue: Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Explorer
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA MR355
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA PET/MR
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR450 1.5T
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Voyager
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR360
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump
The Issue: Improperly performed testing prior to release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA UHP
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA MR380
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA MR360
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR450w 1.5T
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Creator
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750 3.0T
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.