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 37361–37380 of 38,428 recalls
Recalled Item: syngo.plaza
The Issue: There is a potential malfunction in which a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Imaging XS. Radiological image processing system.
The Issue: There is a potential malfunction when using syngo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance 64 and Ingenuity CT are whole body Computed
The Issue: 1. The current system design of software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿
The Issue: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes
The Issue: Covidien is recalling certain cuffed Shiley tracheostomy tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal Reverse Shoulder Liner 40mm
The Issue: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm
The Issue: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck
The Issue: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay
The Issue: Syphilis Assay Interference with HBsAg Assay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model...
The Issue: Addendum Labeling iTotal CR Surgical Technique with Detailed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens
The Issue: Siemens Healthcare Diagnostics has confirmed that partial insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC
The Issue: Siemens has received complaints of customers experiencing slopes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RF Cannula
The Issue: Stryker has received 6 complaints that the 5mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RF Cannula
The Issue: Stryker has received 6 complaints that the 5mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DataCare POC is an information management system that provides
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MagNA Pure 96 System (versions 1.0 and 2.0) is
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.