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 17181–17200 of 38,428 recalls
Recalled Item: HS70A Diagnostic Ultrasound System Version 2.01.00
The Issue: There is a potential for probes overheating when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemospray Endoscopic Hemostat
The Issue: for Hemospray device to be unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle133 Plus Tissue Expander With/Without Suture Tabs
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Komuro
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 150 Full Height and Short Height Implants
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle Inspira
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle and McGhan Silicone-Filled Breast Implants
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGhan Croissant-Shaped Tissue Expanders
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate...
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 410
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 510
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGhan BioDIMENSIONAL silicone-Filled Breast Implants
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Threaded Offset Cup Impactor - Product Usage: To assist the
The Issue: The threaded mechanism of the Threaded Offset Cup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LeMaitre Aortic Occlusion Catheter is a single lumen catheter
The Issue: incorrect device size being listed on the impacted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RITZ PRINCESS
The Issue: The action was initiated following notification by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 'n'-Hole Post which is a component of the Revolution External
The Issue: The threads on posts stripping out when tensioned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.