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 7341–7360 of 38,428 recalls
Recalled Item: Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow ErgoPack Complete
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Marquee Disposable Core Biopsy Instrument Kit
The Issue: Diameter mismatch between coaxial and biopsy needle (cutting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow ErgoPack
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Epiphany Cardio Server E3 ECG Management System Servers with
The Issue: Epiphany, now a Baxter Healthcare company, is issuing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow ErgoPack Pressure Injectable One-Lumen PICC
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow ErgoPack
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (polydioxanone) Suture
The Issue: Internal testing on returned product from this lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II (polydioxanone) Suture
The Issue: Internal testing on returned product from this lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn Connex Spot Monitor
The Issue: Product is being recalled due to the improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proboscis/Piston Assembly
The Issue: Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Asse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with
The Issue: One respirator sample failed a filtration efficiency test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centered Glenosphere w/Screw
The Issue: Centered glenosphere box may contain an eccentric glenosphere
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3ML Syringe Luer Lock with needle 20GX1
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10ML SYRINGE LUER LOCK W/NEEDLE
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10ML SYRINGE LUER LOCK W/OUT NEEDLE
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Iron_2 (IRON_2) Reagents
The Issue: There is a potential for a positive bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.