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 34201–34220 of 38,428 recalls
Recalled Item: GEMINI TF Big Bore PET/CT
The Issue: The TF Big Bore patient table experienced mechanical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compressor Mini To provide a supply of dry
The Issue: Maquet Compressor Mini may deliver compressed air at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symmetry and CODMAN brands
The Issue: The Quad-Lock Sterilization Container System may not maintain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Intermittent noise on ECG and/or Respiration waveforms associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic
The Issue: Complaints were received regarding variability in recovery of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Intermittent noise on ECG and/or Respiration waveforms associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS
The Issue: Update to correct the possibility for patients or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Essenta DR
The Issue: X-ray system C-arm casting may loosen and fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit model 8000 and 8015 with Alaris PCA
The Issue: CareFusion is recalling the Alaris PC unit (model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher
The Issue: Internal testing of the Proteus 235 Proton Therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invivo Corporation Expression Information Portal (Model IP5) is intended to
The Issue: Invivo Corporation located at 12151 Research Parkway, Orlando,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic imaging systems (GEMINI LXL Model #882412
The Issue: The PET Reconstruction Server (PRS) database may randomly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5
The Issue: Sorin is initiating a field correction on S5/C5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin
The Issue: Sorin is initiating a field correction on S5/C5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera
The Issue: The recalling firm determined that visual inspections of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology &
The Issue: Machine Name in TumorLOC Basic Mode is obscured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cervical Extension Machine for Physical Therapy
The Issue: Review of DHRs revealed that HiPot, Continuity, load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lumbar Extension Machine for Physical Therapy
The Issue: Review of DHRs revealed that HiPot, Continuity, load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a
The Issue: The Irrigation Clips were assembled with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABACUS TPN Calculation Software
The Issue: Baxter Healthcare Corporation is issuing a voluntary correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.