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 19201–19220 of 38,428 recalls
Recalled Item: ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed
The Issue: ProSun International LLC discovered discrepancies in their Quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProSun V3 42 Xlc(160w)(10 minutes) tanning bed
The Issue: ProSun International LLC discovered discrepancies in their Quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4
The Issue: Higher than anticipated occurrence of bone fracture during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8
The Issue: Higher than anticipated occurrence of bone fracture during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6
The Issue: Higher than anticipated occurrence of bone fracture during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2
The Issue: Higher than anticipated occurrence of bone fracture during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
The Issue: Product mix up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement
The Issue: Product mix up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter
The Issue: The incorrect outer carton box was used for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number
The Issue: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK STEM with Microporous Surface MP Reconstruction Prosthesis
The Issue: The reaming guide and the guide rod can't
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The...
The Issue: Hemorrhoidal Circular Stapler may have been assembled without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The
The Issue: Hemorrhoidal Circular Stapler may have been assembled without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VisuMax Software Version 2.10.13 with activated Software-Module ReLEx...
The Issue: VisuMax devices with software version 2.10.13 and activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Adapter Percutaneous Pin
The Issue: Under certain circumstances, the percutaneous pin adapter used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vygon DUALSTOP Red Cap used for intravascular lines Product Code:
The Issue: DualStop Caps defect causing leaks in affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vyon DUALSTOP White Cap used for intravascular lines Product Code:
The Issue: DualStop Caps defect causing leaks in affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.