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 33301–33320 of 38,428 recalls
Recalled Item: Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01
The Issue: One lot of ventilation tubes have mixed tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips...
The Issue: for the Fenestrated Grasper Tip jaw to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips
The Issue: for the Fenestrated Grasper Tip jaw to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS (R) Chemistry Products Calibrator Kit 17
The Issue: Calibrator values assigned for the calibrator kit lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS (R) Chemistry Products FS Calibrator 1
The Issue: Calibrator values assigned for the calibrator kit lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that
The Issue: Although the Flat Panel Detector (FPD) touch sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apex Arc Hip Stem
The Issue: Staining on hip implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The
The Issue: There is a potential fire hazard of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton
The Issue: Anomaly with the ProBeam System where under certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Ventilator Flexport Interface
The Issue: Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems
The Issue: Excessive usage of cleaning liquid on Siemens Ysio
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Side Cart assembly
The Issue: Torque wrenches used to tighten certain PSC bolts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in
The Issue: Physio-Control has become aware of incidents where customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System
The Issue: There is a potential for inaccuracies in blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Devon Supine
The Issue: Straps may separate from the foam pad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Pneumatic and Electric Motor Systems. Intended for cutting and
The Issue: Several attachments and handpieces failed to meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MACROLYTE Premie Dispersive Electrode
The Issue: ConMed Corporation has received complaints regarding sparking, no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Medical Ultraview SL Command Module
The Issue: A software anomaly causes temperature alarm limits to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Acetabular System Positioning Guide Post
The Issue: Guide rod may fracture during impaction of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Acetabular System Positioning Guide Rod
The Issue: Guide rod may fracture during impaction of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.