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 29001–29020 of 38,428 recalls
Recalled Item: INTEGRIS Allura 9 (biplane)
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 Biplane OR Table
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Allura Centron
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRIS HM3000
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRIS BV3000 MONO
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 OR Table
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/15
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/20
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIQ FD OR table
The Issue: The use of Allura Xper, Allura Clarity, Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optisure Dual Coil Defibrillation Leads
The Issue: Leads may have been compromised during the manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Software anomaly may allow VITROS Systems to sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: Software anomaly may allow VITROS Systems to sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Chemistry System
The Issue: Software anomaly may allow VITROS Systems to sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Chemistry System
The Issue: Software anomaly may allow VITROS Systems to sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA
The Issue: MYLA¿ software connected to a Laboratory Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.