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 5121–5140 of 38,428 recalls
Recalled Item: Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR)
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T S Model Number (REF): 781347
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems...
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T TX for PET Model Number (REF): 781479
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis: MedStation ES (Main)
The Issue: If automated dispensing cabinets have specific software versions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vivid Ultrasound products
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vivid Ultrasound products
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Interventional Hemodynamic Application R.1.2X
The Issue: for pressure wave data synchronization from two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based
The Issue: Internal product testing failed bubble leak testing (ASTM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaporizer Sevoflurane Maquet Filling
The Issue: Sevoflurane used with the vaporizer may degrade to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical Agilis NxT Steerable Introducer
The Issue: One lot of product has dilators that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL 731 Ventilator (EMV+
The Issue: Operator's Guide & Quick Reference Guide (QRG) ZOLL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.