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 11041–11060 of 38,428 recalls
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD
The Issue: There is an incorrect statement regarding MR Compatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The Issue: The fluoroscopic dose rate might exceed the conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysiosystem with VC10 software version
The Issue: Siemens Healthineers has identified a software error in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag
The Issue: Illegal importation of COVID-19 AG Test kits into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dispensing Pins for Air Inlet Filter
The Issue: This lot may have an elevated risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems....
The Issue: Firm learned of the potential for cracks to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems....
The Issue: Firm learned of the potential for cracks to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempus LS
The Issue: Distribution of Defibrillators that are not approved or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material #
The Issue: Dimension Vista Magnesium Flex reagent cartridge lots exhibiting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAM CHEST SEAL Combo LOT Y060321-09
The Issue: Due to partially assembled valved dressing that has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated)
The Issue: If the CARESCAPE Central Station v2.0 is used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brasseler USA
The Issue: One lot of product was distributed in unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LineSider Spinal System 5.5/6.0mm
The Issue: for weld separation of the Upper Tulip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LineSider Spinal System 5.5/6.0mm
The Issue: for weld separation of the Upper Tulip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LineSider Spinal System 5.5/6.0mm
The Issue: for weld separation of the Upper Tulip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is a handheld ultraviolet-C germicidal wand and contains two
The Issue: Excessive ultraviolet-C radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 630G: MMT-1715
The Issue: New or replacement insulin pumps are not pre-programmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion Extraction Reagent-X
The Issue: Failed stability specifications for reagent kits that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System
The Issue: Updated cleaning instructions are being provided for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.