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 4021–4040 of 38,428 recalls
Recalled Item: Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative
The Issue: This recall was initiated due to customer complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Endoscopic Flushing Pump
The Issue: During product testing, Olympus identified an intermittent loss
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner
The Issue: The bulk product used in the recalling firm's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU
The Issue: Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001
The Issue: installation issue that could result in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation S8 App versions 1.3.0 and 1.3.2
The Issue: Due to two software anomalies that can occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healgen Series Reagent strips for Urinalysis are composed of several
The Issue: The reason for this recall is Healgen Scientific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Code Name: 722282 Azurion 7 M20 722281 Azurion 5
The Issue: Detachment of the Cable Hose Carrier (due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV
The Issue: Detachment of the Cable Hose Carrier (due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura
The Issue: Detachment of the Cable Hose Carrier (due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost
The Issue: Detachment of the Cable Hose Carrier (due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci 5
The Issue: Surgical system Error 23062 due to connector1) Partially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Gastrointestinal Videoscope
The Issue: It was discovered during device performance testing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon Cardiology Hemo. Version 12.2.
The Issue: A potential issue has been identified in Change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortera Spinal Fixation System Screw
The Issue: Spinal fixation system implant screws marked "DNI" are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Cardiology Hemo. Versions 14.2
The Issue: A potential issue has been identified in Change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology Hemo. Versions 13.0
The Issue: A potential issue has been identified in Change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta Implantable Neurostimulator (INS)
The Issue: Model 977006 Vanta INS batterty life has depleted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur aTPO Assay
The Issue: Positive bias in patient results at and below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percussionaire
The Issue: Updated labeling to ensure that blue cap on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.