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 24961–24980 of 38,428 recalls
Recalled Item: Smith & Nephew Dyonics Saw Blade
The Issue: The single use devices are provided sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Dyonics Saw Blade
The Issue: The single use devices are provided sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Dyonics Saw Blade
The Issue: The single use devices are provided sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Dyonics Saw Blade
The Issue: The single use devices are provided sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System
The Issue: It was found that during a procedure the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips V60 Ventilator with Version 2.20 Software
The Issue: The V60 Ventilator with Version 2.20 software installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Final Fit Software Version 1.11 and 1.12
The Issue: During treatment planning, the procedure was programmed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Li (Lithium) Slides
The Issue: Intermittent imprecision in results generated using two specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micropuncture Check-Flo Performer Introducer Set
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriForce Peripheral Crossing Set
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Check-Flo Hemostasis Assembly
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Check-Flo Performer Introducer
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Check-Flo Performer Introducer Set
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Check-Flo Introducer Hausdorf-Lock Atrial
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexor Radial Access Set
The Issue: Devices using a specific hemostatic valve design, referred
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic
The Issue: Certain lots of Sex Hormone Binding Globulin (SHBG)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version
The Issue: Medtronic has identified a software anomaly that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 882480: BrightView designed for single or dual detector nuclear imaging
The Issue: Four issues: 1. Motion controller problem stops scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 882482: BrightView XCT 882454 BrightView X upgrade to XCT
The Issue: Four issues: 1. Motion controller problem stops scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 882478: BrightView X designed for single or dual detector nuclear
The Issue: Four issues: 1. Motion controller problem stops scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.