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 16441–16460 of 38,428 recalls
Recalled Item: iQ200 Series Urine Microscopy Analyzer
The Issue: Customers have reported incidents where two sets of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of
The Issue: Current software version of the Anti-HAV IgM APP-file
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump
The Issue: There is an anomaly in Medfusion 4000 Syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The
The Issue: During the firm's review of May 2019 complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product
The Issue: Medial and lateral polyethylene inserts did not securely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic...
The Issue: commingle of 13 MM and 14 MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual
The Issue: commingle of 13 MM and 14 MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visual-ICE Cryoablation System
The Issue: Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Python Embolectomy Catheters
The Issue: The firm has received reports of tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic
The Issue: The firm has received reports of tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Embolectomy Catheter & 1 ml SYRINGE
The Issue: The firm has received reports of tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide.
The Issue: Certain dilation and extension catheters are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged
The Issue: Certain dilation and extension catheters are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebel Monorail PtCr Coronary Stent System
The Issue: Certain dilation and extension catheters are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide....
The Issue: Certain dilation and extension catheters are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT -
The Issue: Sterile packaging incomplete seals may compromise sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENTLEWAVE
The Issue: The console would continue to run for extended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity c Carbon Dioxide Reagent Kit
The Issue: Abbott internal studies have determined that atmospheric Carbon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Acetabular System
The Issue: The firm received complaints that the EMPOWR Acetabular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMERIEUX VIDAS 3
The Issue: Following Customers complaints, investigations have been initiated on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.