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 28941–28960 of 38,428 recalls
Recalled Item: Philips Healthcare DuraDiagnost stationary X-ray system
The Issue: The detector may signal that it is ready
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arctic Sun 5000 and Arctic Sun 2000
The Issue: Improper targeted temperature therapy was delivered to patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response
The Issue: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is
The Issue: The firm is recalling the Shimadzu Mobile X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Screw Driver SJ706R
The Issue: The flexible shaft of the instruments may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger
The Issue: The firm identified a malfunction which made it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Drill
The Issue: The flexible shaft of the instruments may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reagent Management System (RMS) Dimension EXL with LM STM Product
The Issue: Siemens has identified RMS refrigeration compressors that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tray Set containing multiple instruments and may contain the flexible bone awl
The Issue: The flexible shaft of the instruments may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reagent Management System (RMS) Dimension RxL Max HM STM Product
The Issue: Siemens has identified RMS refrigeration compressors that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Bone Awl
The Issue: The flexible shaft of the instruments may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger
The Issue: The firm identified a malfunction which made it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reagent Management System (RMS) Dimension EXL with LM Product Usage:
The Issue: Siemens has identified RMS refrigeration compressors that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reagent Management System (RMS) Dimension RxL Max w/o HM Product
The Issue: Siemens has identified RMS refrigeration compressors that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Infusion Pump
The Issue: A small number of specific pumps may trigger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Infusion Pump
The Issue: A small number of specific pumps may trigger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arctic Sun Temperature Management System
The Issue: The product may contain electronic components that lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT
The Issue: One lot of 35 mm patella implants is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic InSync III
The Issue: Medtronic has confirmed an issue with InSync III
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remote Patient Monitoring System
The Issue: Testing at customer site showed unit Remote Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.