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 12521–12540 of 38,428 recalls
Recalled Item: Medtronic HY7M07R6
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CB1H18R20
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HY8M63R4
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HY8R62R13
The Issue: Specific lots may have been manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 026-20036A Liberty Drain Line
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Drain Bag Set (tubings and flexible bags) is a passive
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Fresenius APD Luer-Lock Adapter
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MTS Set is a single-use
The Issue: Exposed to freezing temperatures due to refrigerated truck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox RX Imola Analyser with ISE
The Issue: An issue was identified where the software froze
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II
The Issue: Incorrect stentstop assembly (18fr) was used to build
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
The Issue: In rare situations patients infected with high viral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Better-Bladder (BB)
The Issue: The device is used as part of extracorporeal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quanta System Sterile Optical Laser Fiber
The Issue: Product sterility is potentially compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Sterile Optical Laser Fiber
The Issue: Product sterility is potentially compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Braive Growth Modulation System Break-Off Set Screws - Product Usage:
The Issue: Product is impacted by a thread profile defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.