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 27561–27580 of 38,428 recalls
Recalled Item: Boston Scientific
The Issue: Boston Scientific is voluntarily implementing a Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
The Issue: The fasteners securing the control panel assembly to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum 360 is a large volume infuser capable of
The Issue: Firm's investigation determined that the Proximal Occlusion Alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein Single Use Syringe Luer-Lock
The Issue: BD 10 mL Syringe Luer-Lok Tip with BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ is a dual-line volumetric infusion system designed
The Issue: Firm's investigation determined that the Proximal Occlusion Alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein Single Use Syringe Luer-Lock
The Issue: BD 10 mL Syringe Luer-Lok Tip with BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe
The Issue: Monteris received a report that the sapphire lens
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB Sciex Triple Quad 4500MD LC/MS/MS System
The Issue: Under certain conditions, mass spectrometers may report incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Robotic Catheter Accessory Kits
The Issue: Firm's quarterly dose audit testing showed that one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist Stapler 45 and Stapler 30 instruments used on the
The Issue: for unexpected motion of the Xi Stapler
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Weck EFx Classic Fascial Closure System
The Issue: Incorrect expiration date was printed on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16 Computed Tomography X-ray systems is intended to produce
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance BigBore Oncology Computed Tomography X-ray systems
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray systems is intended to
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance BigBore Radiology Computed Tomography X-ray systems
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Computed Tomography X-ray systems is intended to produce
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16 Power Computed Tomography X-ray systems is intended
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray systems is intended to produce
The Issue: Software defect causing intermittently slow response of Host
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Nitrocefin (+ Reconstitution Fluid Batch)
The Issue: Individual bottles of product may produce weak beta-lactamase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ARCHITECT Estradiol Kit Intended to measure estradiol
The Issue: Interaction of Fulvestrant with the ARCHITECT Estradiol assay,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.