Go Backs

Monitoring Devices

AllImplants & Prosthetics(225)Monitoring Devices(270)Diagnostic Equipment(818)Home Healthcare(231)Contact Lenses & Vision(17)Surgical Equipment(890)

270 recalls

per page
Smiths Medical PM
Medium RiskFDA Vet

Smiths Medical PM, Inc.: Medical Device AC Power Cords Recalled Due to Electrical Concerns

  • Sold in 37 states
  • Sold at Smiths Medical PM, Inc., Electri-Cord Manufacturing Co.
Recalled
Added
Smiths Medical ASD
Low RiskFDA Vet

Smiths Medical ASD, Inc.: Medfusion Syringe Infusion Pumps Recalled for Over-Delivery Risk

  • Sold in Florida, New York, Virginia
  • Sold at Authorized distributors
Recalled
Added
Hospira
Medium RiskFDA Vet

Hospira Inc.: Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob

  • Sold in 20 states
  • Sold at Authorized veterinary distributors, Direct sales from Hospira Inc.
Recalled
Added
Masimo
Medium RiskFDA Vet

Masimo Rad-G Pulse Oximeters Recalled for Unexpected Power Loss

  • Sold in 45 states
  • Sold at Authorized Medical Distributors, Direct Sales
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed Automated Impella Controller Recalled for Delayed Alarms

  • Distributed nationwide
  • Sold at Direct from manufacturer, Authorized medical device distributors
Recalled
Added
Covidien
Medium RiskFDA Device

HealthCast Vital Sync Remote Patient Monitoring System Recalled for Alarm Failure

  • Sold in 22 states
  • Sold at direct-to-hospital sales, medical equipment distributors
  • Complaints and investigations into failed alarm transmissions
Recalled
Added
CareFusion 303
Medium RiskFDA Device

BD Alaris Pump Module 8100 Recalled for Network Connectivity Issues

  • Sold in 4 states
  • Sold at Hospital networks, Medical device distributors
Recalled
Added
Maquet Medical Systems USA
Medium RiskFDA Device

Maquet Medical Systems USA: CARDIOHELP-i Systems Recalled for Excessive Patient Leakage Current

  • Sold in New Jersey, Texas
  • Sold at Maquet Medical Systems USA
Recalled
Added
Physio-Control
Medium RiskFDA Device

LIFEPAK 35 ECG Cables Recalled for Missing Cleaning and Disinfection Instructions

  • Sold in 18 states
  • Sold at Physio-Control, Inc. authorized distributors
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Pyxis CII Safe ES Recalled for Software Defect Enabling Drug Diversion

  • Sold in 9 states
  • Sold at CareFusion 303, Inc., BD (Becton, Dickinson and Company)
Recalled
Added
Coapt
Medium RiskFDA Device

Coapt LLC: ControlSeal Cutaneous EMG Electrodes Recalled for Burn and Blistering Risk

  • Distributed nationwide
  • Sold at Worldwide distribution, US Nationwide
Recalled
Added
Zoll Medical
High RiskFDA Device

Zoll Medical Corporation: Powerheart G5 AEDs Recalled Due to Protective Film Blocking Shock Button

  • Distributed nationwide
  • 14,885 units affected
Recalled
Added
Boston Scientific
Medium RiskFDA Device

Boston Scientific Corporation: myLUX Patient Application Recalled for Cardiac Data Transmission Failure

  • Sold in 19 states
  • Sold at Apple App Store
Recalled
Added
Contec Medical Systems
Medium RiskFDA Device

Contec CMS8000 Patient Monitors Recalled for Cybersecurity Vulnerabilities

  • Sold in 5 states
  • Sold at medical equipment distributors
Recalled
Added
Thoratec
Critical RiskFDA Device

Thoratec Corp.: HeartMate System Monitor Recalled for Screen Freezing and Command Errors

  • Distributed nationwide
  • Sold at Authorized medical distributors, Hospitals +1 more
  • Potential for anxiety, hemodynamic compromise, and extended surgical time mentioned; no specific injury count provided.
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospital Equipment Providers
Recalled
Added
Capnia
Medium RiskFDA Device

Capnia Precision Sampling Set Nasal Cannulas Recalled for Chemical Residue

  • Sold in 6 states
  • Sold at Medical distributors, Healthcare facilities
  • Carbon monoxide, Volatile organic compounds contamination
Recalled
Added
Murata Vios
Medium RiskFDA Device

Murata Vios Monitoring System Model 2050 Recalled for Display Distortion

  • Sold in 4 states
  • Sold at authorized medical equipment distributors
Recalled
Added
High RiskFDA Device

Inseego USB8 4G Dongle Kits Recalled for Outdated Software Risks

  • Sold in 5 states
  • Sold at Medical equipment distributors
Recalled
Added
Medium RiskFDA Device

Tempus Pro Patient Monitors Recalled for Software Error Screen Issue

  • Sold in 42 states
Recalled
Added
Draeger Medical
Critical RiskFDA Device

Draeger Medical, Inc.: Perseus A500 Anesthesia Workstations Recalled for Unexpected Shutdown

  • Distributed nationwide
  • Sold at hospital distributors, medical equipment suppliers
  • 16,841 units affected
Recalled
Added
Securitas Healthcare
Medium RiskFDA Device

Arial 900 MHz Call Stations Recalled for Battery Alert Firmware Issue

  • Distributed nationwide
  • Sold at Authorized Healthcare Distributors, Direct Sales
Recalled
Added
RAYSEARCH LABORATORIES AB
Medium RiskFDA Device

RAYSEARCH LABORATORIES AB: RayCare Oncology Software Recalled for Missing Medication Allergy Warnings

  • Sold in Tennessee
  • Sold at Direct Sales
Recalled
Added
Turncare
Medium RiskFDA Device

Guardian 2 System Controllers Recalled for Missing Battery Alerts

  • Sold in 5 states
  • Sold at Authorized distributors, Hospitals +1 more
Recalled
Added