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 30561–30580 of 38,428 recalls
Recalled Item: 98" (249 cm) Transfer Set w/MicroClave T-Connector
The Issue: ICU Medical is recalling MicroClave T-Connectors because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Alignment Guide
The Issue: Zimmer CAS has determined that the potential exists
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GMK Hinge knee prosthesis
The Issue: Incorrect parts: Packages of the GMK Hinge Tibial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal(R) Medium Specimen Retrieval Bag
The Issue: The firm received reports of specimen retrieval bags
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
The Issue: The operator console allows users to deliver therapeutic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultraview SL Command Modules
The Issue: Ultraview SL Command Modules which were upgraded with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WEBSTER HIS Catheter
The Issue: The Webster HIS catheter, 4Pole Fixed Curve with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Echelon MRI System
The Issue: Image data transferred from the MRI system to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Oasis MRI System
The Issue: Image data transferred from the MRI system to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Echelon Oval MRI System
The Issue: Image data transferred from the MRI system to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASC (Breast) Kit
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Basin Kits
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Devon Light Gloves
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE...
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Basin Kit
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minor Surgical Kits
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augmentation Kit
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Major Kit
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hysto Pack
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mini-Kits
The Issue: Devon Light Gloves contain splits or holes compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.