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 33501–33520 of 38,428 recalls
Recalled Item: Shimadzu Digital Radiography X-Ray System
The Issue: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iLab Ultrasound Imaging System
The Issue: Specific iLab Ultrasound Imaging Systems using newest 3.0
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Circular Lock Screws
The Issue: The recall is being initiated because MK Precision
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABACUS TPN Calculation Software
The Issue: 1. ABACUS v3.1 may calculate quantities of electrolytes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared
The Issue: Medical device software may be defective and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda¿ Freestanding Infant Warmers
The Issue: Medical device software may be defective and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat
The Issue: Medical device software may be defective and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nellcor SpO2 Upgrade kit
The Issue: Medical device software may be defective and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda¿ Wall-Mount Infant Warmers
The Issue: Medical device software may be defective and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software
The Issue: Philips MDC PACS Release R2.x and Philips IntelliSpace
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00
The Issue: When fourSight 4D ultrasound imaging, 3-Scrape real time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: safety issue with gradient coil electromechanical connections
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL+ Defibrillator/Monitor with system software version...
The Issue: Software communication failure may occur on the HeartStart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIPRO SafeTouch II Safety AVF Needle
The Issue: Device has the potential to have torn wings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7F NeuroFlo Catheter
The Issue: After aquisition of assets of CoAxia, Zoll discovered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series
The Issue: A customer reported that the table top had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray...
The Issue: Siemens Radiation Oncology became aware that customers may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)
The Issue: Table may lose calibration during patient treatment, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PS-C Femoral Nonporous Rt Sz 6
The Issue: A femoral component containing pegs was found in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRABECULAR METAL MODULAR ACETABULAR SYSTEM
The Issue: The shell was missing the locking ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.