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 32981–33000 of 38,428 recalls
Recalled Item: BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System
The Issue: A portion of the BBL Crystal Enteric/Nonfermentor (E/NF)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IRK QRG for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Manual for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connection QRG for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stapler Addendum for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insert for IRK for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vision Troubleshooting Guide for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cautery QRG for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vessel Sealer QRG for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Site US Manuals and Single Site OUS Manuals for
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natural Rubber Latex QRG for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vessel Sealer Addendum for the da Vinci Standard Surgical System
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endowrist Instrument and Accessory Manual for the da Vinci Standard
The Issue: Multiple updates to User Manuals, Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra UCR 3mm Hex
The Issue: Integra has identified through an investigation of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche MODULAR ANALYTICS EVO Serum Work Area (SWA)
The Issue: Under certain conditions loose ProCell/CleanCell aspiration tube filters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 8000 analyzer series Operators Manual Roche cobas Filter label:
The Issue: Under certain conditions loose ProCell/CleanCell aspiration tube filters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH Easy Cath Coude Kit
The Issue: Product was packaged with a straight catheter rather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory
The Issue: The interface fails to send abnormal flags for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50"
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAP Abdom w/pouch Customed code 900-2619
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.