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 22001–22020 of 38,428 recalls
Recalled Item: LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for
The Issue: The incorrect placement of AA batteries into certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.via. Medical Device Software. Picture archiving and communications system.
The Issue: A software functionality in the report sections Findings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excella II Polyaxial Pedicle Screw used as a pedicle screw
The Issue: Nine lots of 8.5 mm Polyaxial Pedicle Screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro
The Issue: Contains a gel-like contaminant that may affect product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro
The Issue: Contains a gel-like contaminant that may affect product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemodynamic monitoring system (HMS)
The Issue: When continuous cardiac output monitoring with a pulmonary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis angiographic x-ray system
The Issue: Certain systems may have leaking of the plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)
The Issue: Increase of events affecting performance regarding pump clogging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioMerieux mini VIDAS System in combination with Quality Control VIDAS*
The Issue: Increase of events affecting performance regarding pump clogging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic Ultrasound System
The Issue: The power supply unit may be damaged and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper systems with Certeray X-ray Generator located in regions
The Issue: There is an increase in the failure rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rheumatoid Factor (RF) Kit for use on SPAPLUS
The Issue: The low and high controls for the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance(R) Percutaneous Shaft 36cm
The Issue: There is potential for a piece of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance(R) Percutaneous Shaft 29cm
The Issue: There is potential for a piece of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMASHIELD Knitted Double Velour Cardiovascular Fabric
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyLab Ultrasound System
The Issue: The ultrasound system used in certain settings may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyLab Ultrasound System
The Issue: The ultrasound system used in certain settings may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal¿ Primary Hip Prosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #'
The Issue: Software issues including: Software errors that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore Radiology CT with 4.2.0 software version. Model
The Issue: Software issues including: Software errors that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.