Go Backs

Monitoring Devices

AllImplants & Prosthetics(228)Monitoring Devices(259)Diagnostic Equipment(818)Home Healthcare(219)Contact Lenses & Vision(17)Surgical Equipment(898)

259 recalls

per page
Philips North America
Medium RiskFDA Device

Philips North America: Patient Information Center iX and CareEvent Recalled for Notification Failure

  • Sold in 15 states
  • Sold at Philips North America
Recalled
Added
Dexcom
Critical RiskFDA Device

Dexcom Glucose Receivers Recalled for Defective Speaker Alerts

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Pharmacies
  • 703,687 units affected
Recalled
Added
Ambu
Medium RiskFDA Device

Ambu Inc.: aView 2 Advance Monitor Recalled for Fire and Smoke Risk

  • Distributed nationwide
  • Sold at Ambu Inc.
Recalled
Added
Medtronic MiniMed
Medium RiskFDA Device

Medtronic CareLink Clinic Software Recalled for Incorrect Glucose Graph Data

  • Distributed nationwide
  • Sold at Medtronic, Hospitals +2 more
  • 12,126 units affected
Recalled
Added
Thoratec
Critical RiskFDA Device

Thoratec Corp.: HeartMate Touch Communication System Recalled for Unexpected Pump Failures

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospitals
Recalled
Added
High RiskFDA Device

Remote Diagnostic Technologies Ltd.: Tempus Pro Patient Monitors Recalled for Screen Error and Restart Risks

  • Sold in 42 states
  • Sold at Authorized Medical Distributors
Recalled
Added
RONAN MEDICAL
Medium RiskFDA Device

RONAN MEDICAL LLC: Neurofeedback Systems Recalled for Documentation and Performance Issues

  • Sold in 6 states
  • Sold at RONAN MEDICAL LLC
Recalled
Added
Dexcom
Medium RiskFDA Device

Dexcom G7 iOS App Recalled for Stale Glucose Reading Bug

  • Distributed nationwide
  • Sold at Apple App Store
  • 61,355 units affected
Recalled
Added
Physio-Control
High RiskFDA Device

Physio-Control, Inc.: LIFEPAK 15 AC Power Adapters Recalled for Power and Charging Failure

  • Sold in 50 states
  • Sold at Physio-Control, Inc., Medical supply distributors
  • 18,732 units affected
Recalled
Added
Datex-Ohmeda
Critical RiskFDA Device

Datex-Ohmeda, Inc.: EVair and EVair 03 Air Compressors Recalled for Elevated Formaldehyde Levels

  • Distributed nationwide
  • Sold at GE HealthCare Authorized Dealers, Direct Medical Sales
  • Formaldehyde contamination
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Novum IQ Syringe Pump Recalled for Syringe Detection Issue

  • Distributed nationwide
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
First Source
Medium RiskFDA Device

First Source Inc: Vision M and iQ Flex M Portable Carts Recalled for Falling Bolt Risk

  • Sold in 19 states
  • Sold at First Source Inc
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs DVI Display Cables Recalled for Electromagnetic Interference Risk

  • Sold in 44 states
  • Sold at Spacelabs Healthcare, Inc., Medical device distributors
  • 25,897 units affected
Recalled
Added
Abiomed
Critical RiskFDA Device

Automated Impella Controller (AIC) Recalled for Cybersecurity Vulnerabilities

  • Distributed nationwide
  • Sold at Hospitals, Medical Centers +2 more
  • 10,153 units affected
Recalled
Added
Smiths Medical ASD
Medium RiskFDA Device

Smiths Medical ASD Inc.: Medfusion Syringe Pumps Recalled for Sensor Calibration and Alarm Issues

  • Distributed nationwide
  • Sold at Direct distribution to hospitals and clinics
  • 109,608 units affected
Recalled
Added
Trividia Health
Medium RiskFDA Device

Good Neighbor Pharmacy Glucose Meters Recalled for Display Defects

  • Sold in 7 states
  • Sold at Good Neighbor Pharmacy
Recalled
Added
Outset Medical
Medium RiskFDA Device

Tablo Hemodialysis Consoles Recalled for Faulty Blood Leak Sensor

  • Sold in 46 states
  • Sold at Authorized Medical Device Distributors, Hospitals +1 more
Recalled
Added
GE Medical Systems
Medium RiskFDA Device

Portrait Core Services Software Recalled for Patient Monitoring Loss

  • Sold in Ohio, Texas
  • Sold at GE Medical Systems authorized channels, Healthcare facilities
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: EarlyVue VS30 Vital Signs Monitors Recalled for Software Alarm Failure

  • Sold in Massachusetts, Michigan
  • Sold at Direct Sales
Recalled
Added
EITAN MEDICAL
Critical RiskFDA Device

EITAN MEDICAL LTD: Sapphire Infusion Pumps Recalled for Potential Failure to Detect Air in Line

  • Distributed nationwide
  • Sold at Authorized distributors, Medical facilities
Recalled
Added
Medium RiskFDA Device

GE Medical Systems Information Technologies Inc: CRITIKON ONE-CUF Blood Pressure Cuffs Recalled for Inaccurate Measurements

  • Sold in 20 states
  • Sold at GE Medical Systems, Medical Distributors
  • 23,180 units affected
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien LP: Palindrome Chronic Catheters Recalled for Missing Heparin Coating

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
Recalled
Added
Physio-Control
Medium RiskFDA Device

Physio-Control LIFEPAK Defibrillators Recalled for Missed Service Inspections

  • Sold in Colorado, Montana
Recalled
Added
Medium RiskFDA Device

Terumo CDI OneView BPM Probes Recalled for Inaccurate Temperature Readings

  • Sold in 10 states
  • Sold at Authorized medical distributors
Recalled
Added