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 10541–10560 of 38,428 recalls
Recalled Item: Drager SafeStar 55
The Issue: occlusion of filters due to manufacturing error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips OmniWire Pressure guide wire PN 300000252891
The Issue: Due to a potential failed sterilization process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EEA Autosuture Circular Stapler with DST Series Technology
The Issue: The affected staplers have the potential for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano Visions PV. 035 Digital IVUS Catheter
The Issue: Digital IVUS catheter instructions for use ( IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano Visions PV. 035 Digital IVUS Catheter
The Issue: Digital IVUS catheter instructions for use ( IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip
The Issue: There is a potential for reduced analytical sensitivity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Pill Splitters
The Issue: Product lid (which houses a blade) is coming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Clareon IOL with AutonoMe Delivery System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VYGON DRESSING CHANGE W/MAXISWAB kit
The Issue: for incomplete seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Central Station (CSCS) V2
The Issue: The CARESAPE Central Station (CSCS) V2 can shut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapor-Clean
The Issue: Due to a manufacturing issue that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta" Plus3 White Blend OEM (sterile
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.