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 15981–16000 of 38,428 recalls
Recalled Item: Ysio Max
The Issue: A software bug may lead to one image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max
The Issue: Siemens became aware of an issue of incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max
The Issue: A software bug may lead to one image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF Max
The Issue: Siemens became aware of an issue of incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF Max
The Issue: A software bug may lead to one image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uroskop Omnia max
The Issue: Siemens became aware of an issue of incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only
The Issue: Sterile drapes packaged in an unsealed pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally
The Issue: Sterile drapes packaged in an unsealed pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin
The Issue: Lots of Smiths Medical Portex Pro-Vent and LineDraw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin
The Issue: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America BodyGuard Infusion Pump System
The Issue: Infusion Pump Systems may have a delivery inaccuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THP Hip Plating System
The Issue: increase in fracture rate was detected during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas infinity core
The Issue: Alarm flags that have a "<" symbol in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cocoon Convective Warming System
The Issue: for thermal damage near the power cord
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cocoon Convective Warming System
The Issue: for thermal damage near the power cord
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made
The Issue: There is potential for the sterile wrap to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL...
The Issue: Slow degradation of plastic insulation used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
The Issue: Slow degradation of plastic insulation used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
The Issue: Slow degradation of plastic insulation used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
The Issue: Slow degradation of plastic insulation used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.