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 3981–4000 of 38,428 recalls
Recalled Item: Implant Epikut S Plus CM 16-Degrees 4
The Issue: Dental implant box incorrectly labels the diameter as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o
The Issue: Due to an out of tolerance tool being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Predict+ is a data-driven
The Issue: Predict+ is being recalled for lack of pre-market
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Melrose Wakefield Hospital Injector And Syringe
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Inflation Device 30 atm/bar Injector And Syringe
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Automatic Digital Blood Pressure Monitor
The Issue: It has been determined that certain Blood Pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value
The Issue: Due to a manufacturing process resulting in holes/breaches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT
The Issue: It has been determined that certain Blood Pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT
The Issue: It has been determined that certain Blood Pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Trevo Trak 21 Microcatheter is a single-lumen
The Issue: Stryker Neurovascular has observed that devices with Out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neo-Tee T-Piece Resuscitator. Part Numbers 1050805
The Issue: Manual resuscitator circuit flow controller may come apart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: The software has anomalies that have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX400 (Model Number 866060)
The Issue: During a production process, Philips became aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical Hemo-7 Hemospray Endoscopic Hemostat
The Issue: Specific lots of product have been manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Universal Viewer Zero Footprint Client
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for
The Issue: Manufactured with a misaligned axis resulting in lenses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for
The Issue: Manufactured with a misaligned axis resulting in lenses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.