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 27121–27140 of 38,428 recalls
Recalled Item: Norian Drillable Inject 5 CC-Sterile
The Issue: DePuy Synthes is initiating a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Pump RF Patient Cassette
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIOOA I (EP I84) Rabbit Monoclonal Antibody
The Issue: Cell Marque became aware of some lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Synapse PACS software version 4.4.000
The Issue: Synapse cannot display image files, DICOM SR files,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip
The Issue: Firm received complaints where the Piccolo Composite Ball
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TS Series Depth Gauge for Integra Ti6 Internal Fixation System
The Issue: As a result of an internal investigation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Software error in previous software versions in which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas¿ Liat¿ Analyzer
The Issue: Device was released with default pcal/gain settings for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products AFP Reagent Pack
The Issue: Ortho Clinical Diagnostics (OCD) confirmed that specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal
The Issue: The device was found to have bacterial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Small Patient ECC Pack
The Issue: Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Revolution CT The system is intended for head
The Issue: GEHC has become aware of a potential safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MSK 1.5T Extreme MR Scanner
The Issue: The gas venting may not occur properly. A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima 1.5T MR430s MR Scanner
The Issue: The gas venting may not occur properly. A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEAL
The Issue: for particulates in insufflation stopcocks on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEAL
The Issue: for particulates in insufflation stopcocks on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists
The Issue: for the Visualase Cooled Laser Applicator System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel
The Issue: A diode was inadvertently not assembled into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Best Theratronics cabinet x-ray systems intended for use in the
The Issue: It was discovered that both the new device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotine Transbleph 3.5 (CFD-080-0167)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.