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 26381–26400 of 38,428 recalls
Recalled Item: TECNIS 1-Piece IOL
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
The Issue: The handle can separate from the MRx housing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS Multifocal 1-Piece Intraocular Lens
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: United Nuclear Scientific High Power Handheld Lasers. Laser products
The Issue: Failure to comply with the laser class limitation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista IRON Flex reagent cartridges
The Issue: Siemens Healthcare Diagnostics has become aware of deferoxamine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension IRON Flex reagent cartridges
The Issue: Siemens Healthcare Diagnostics has become aware of deferoxamine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Inflation Syringe Kit. Catalog Number KOS-02857
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item
The Issue: NatalCare LX incubators may have a defective base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)
The Issue: The firm received multiple reports of Xhibit Telemetry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Xhibit Central Station
The Issue: The firm received multiple reports of Xhibit Telemetry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation)...
The Issue: Products contain international package insert and not the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation)...
The Issue: Products contain international package insert and not the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St¿ckert S5 System
The Issue: Sorin/LivaNova is initiating a field correction on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tego Connector
The Issue: ICU Medical Inc. has identified a potential risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glucose Tolerance Beverage- Orange 50 gram Concentration
The Issue: Out of Specification Microbiological test results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fruit Punch Glucose
The Issue: Out of Specification Microbiological test results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM)
The Issue: Siemens received multiple customer complaints indicating an increase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM)
The Issue: Siemens received multiple customer complaints indicating an increase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray
The Issue: The infant performance test did not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.