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 36501–36520 of 38,428 recalls
Recalled Item: AMO Sensar Intraocular Lenses (IOLs)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An
The Issue: The analytical sensitivity claim of 6 ug/dL (1.1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 6
The Issue: Philips Healthcare received reports from the field stating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthTronics Endocare 3.8mm RenalCryo Cryoprobe
The Issue: The Endocare 3.8mm RenalCryo Cryoprobe is being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer
The Issue: CareFusion is recalling the SmartSite¿ Gravity Blood Set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension(R) IRON Calibrator (DC85)
The Issue: Siemens Healthcare Diagnostics has received complaints of IRON
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medisystems 17 Gauge x 1" inch AV Fistula Needle Product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlowGate Balloon Guide Catheter
The Issue: Firm received complaints of resistance and possible collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent
The Issue: Siemens has confirmed an increase on absorbance errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1
The Issue: The DICOM tags do not contain sufficient information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips MX 16-Slice CT Scanner System
The Issue: The four screws that secure the patient table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON
The Issue: Analysis of a customer complaint has shown that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical microscope The device is used to improve the visibility
The Issue: The brake in the Z axis and/or brakes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical microscope The device is used to improve the visibility
The Issue: The brake in the Z axis and/or brakes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters with Blade Disarmer
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters with Blade Disarmer
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.