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 34221–34240 of 38,428 recalls
Recalled Item: MAS Omni Immune PRO Controls
The Issue: The constituent, Inhibin A, was removed from MAS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAS Omni Immune Controls
The Issue: The constituent, Inhibin A, was removed from MAS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: steroEOS Workstation with software versions: 1.3
The Issue: Error copying information to the clinical file and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE has become aware of multiple issues affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carescape Patient Data Module The Patient Data Module
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay
The Issue: The Access 2 Immunoassay System Analyzer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System Analyzer. The Access Immunoassay System is
The Issue: The Access 2 Immunoassay System Analyzer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver
The Issue: Orthofix received 6 complaints which resulted in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Interlink threaded lock cannula This is a locking blunt
The Issue: BD Interlink Threaded Lock Cannula REF# 303369 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE
The Issue: Shipped femur guide contained a non-conformance which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD Cyclesure Biological Indicator (BI
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Secure II Med/Surg Bed Secure II and the 3002 S3
The Issue: Stryker Medical has identified a potential issue associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S3 Med/Surg Bed Secure II and the 3002 S3 are
The Issue: Stryker Medical has identified a potential issue associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra
The Issue: Integra became aware through a complaint from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit
The Issue: Integra LifeSciences is voluntarily recalling any unexpired lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
The Issue: Investigation identified that the outer label, inner label,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: outer box:
The Issue: Inner label of PN: 906768 Lot: 055450 CurvTek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InstaTrak¿ 3500 Plus
The Issue: GE OEC Medical Systems Inc is recalling InstaTrak¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agility. Version 3.0 of the Integrity interface and control software
The Issue: During the treatment table, gantry, and collimator calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Desktop Pro TM linear accelerator control software intended to assist
The Issue: During the treatment table, gantry, and collimator calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.