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 32421–32440 of 38,428 recalls
Recalled Item: STAT 2 Flow Controller
The Issue: ICU is recalling the ConMed Stat 2 flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 98" (249 cm) Appx 12.3 ml
The Issue: ICU is recalling the ConMed Stat 2 flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens CentraLink Data Management System
The Issue: Siemens Healthcare Diagnostics has identified a task scheduler
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse Implantable Cardioverter Defibrillators (ICDs)
The Issue: An anomaly may result in delayed, partial, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Licox Pt02 Monitor
The Issue: Integra LifeSciences Corporation received 2 complaints that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista¿ CHEM 1 CAL
The Issue: Siemens Healthcare Diagnostics has received complaints for low
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4D Integrated Treatment Console (4DITC)
The Issue: Due to user error, the 4DITC can improperly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FOCAL Sim Workstation
The Issue: When DICOM is exporting an arc plan (VMAT,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Echelon Oval MRI system is a diagnostic imaging device
The Issue: The Gradient Coil was found to have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco The Monaco system is used to make treatment plans
The Issue: Incorrect Delivery of Composite VMAT Fields - When
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Howmedica Osteonics RESTORATION Acetabular Augment System
The Issue: The peel strength of the inner blister may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.
The Issue: The peel strength of the inner blister may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp.
The Issue: The peel strength of the inner blister may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Array LaserLink
The Issue: Lumenis initiated a field-correction for the Array Laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAP-BAND AP SYSTEM AP Large with Access Port
The Issue: Product was distributed past its expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below
The Issue: issues with the ProVue driver have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hancock Apical Left Ventricle Connector
The Issue: Medtronic has decided to discontinue production and distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Electric Drive (SED). For use in general traumatology.
The Issue: The affected Small Electric Drive (SED) may operate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAM Junctional Tourniquet (SJT) Auxiliary
The Issue: SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ HbA1c
The Issue: In March, Siemens Healthcare Diagnostics issued an Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.