Go Backs

Monitoring Devices

AllImplants & Prosthetics(226)Monitoring Devices(263)Diagnostic Equipment(818)Home Healthcare(223)Contact Lenses & Vision(17)Surgical Equipment(895)

263 recalls

per page
Sophysa
Medium RiskFDA Device

Sophysa Pressio 2 ICP Monitoring Systems Recalled for Unexpected Rebooting

  • Sold in 9 states
  • Sold at Authorized medical equipment distributors
Recalled
Added
SenTec AG
Medium RiskFDA Device

SenTec AG: Sentec Digital Monitoring System Components Recalled for Measurement Errors

  • Distributed nationwide
Recalled
Added
Dexcom
Medium RiskFDA Device

Dexcom G6 Glucose Receivers Recalled for Delayed Alarms and Reading Errors

  • Sold in 11 states
  • Sold at Authorized Medical Distributors, Specialty Pharmacies
Recalled
Added
Nova Biomedical
Critical RiskFDA Device

Nova Biomedical StatStrip Hospital Meters Recalled for Software Bug

  • Distributed nationwide
  • Sold at Healthcare institutions, Hospitals
Recalled
Added
Smiths Medical Asd
Medium RiskFDA Device

Smiths Medical Asd Inc: Medical Infusion Tubing and Stopcocks Recalled for Potential Leaks

  • Distributed nationwide
  • Sold at Hospital supply distributors, Medical device wholesalers
  • 31,685 units affected
Recalled
Added
Getinge Usa Sales
Medium RiskFDA Device

Getinge Usa Sales Inc: Flow Anesthesia Systems Recalled for Cybersecurity Vulnerabilities

  • Sold in 20 states
  • Sold at Direct Sales, Medical Supply Distributors
Recalled
Added
Medium RiskFDA Device

Medline Namic Pressure Monitoring Lines Recalled for Fluid Blockage Risk

  • Distributed nationwide
  • Sold at Hospital supply channels, Medline direct sales
Recalled
Added
CardioQuip
Medium RiskFDA Device

CardioQuip, LLC: Modular Cooler-Heater Recalled Due to Heating Chamber Malfunction and Fire Risk

  • Sold in 15 states
  • Sold at Hospitals and medical facilities, Direct distribution
Recalled
Added
HeartSine Technologies
High RiskFDA Device

HeartSine Technologies Ltd: HeartSine samaritan Defibrillators Recalled for Voice Prompt Failure

  • Sold in 56 states
  • Sold at Authorized distributors
  • 183,248 units affected
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Welch Allyn Blood Pressure Systems Recalled for Undeclared Latex

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • Undeclared latex, natural rubber
Recalled
Added
Hamilton Medical
Critical RiskFDA Device

Hamilton Medical, Inc.: Hamilton Ventilators Recalled for Risk of Power Short and Breathing Interruption

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Hamilton Medical, Inc.
Recalled
Added
Thoratec Switzerland
High RiskFDA Device

Thoratec Switzerland GMBH: CentriMag Primary Console Recalled Due to Power Surge Shut Down Risk

  • Sold in 37 states
  • Sold at Authorized Medical Distributors, Hospitals
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips IntelliBridge and IntelliVue Devices Recalled for Alarm Failure

  • Sold in Florida, North Carolina, Oregon
  • Sold at Authorized Medical Distributors, Direct Sales
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: Patient Information Center iX Software Recalled for Settings Sync Failure

  • Distributed nationwide
  • Sold at Philips North America, Healthcare distributors
Recalled
Added
Medtronic MiniMed
Critical RiskFDA Device

Medtronic MiniMed, Inc.: MiniMed Insulin Pumps Recalled Due to Battery Depletion and Power Loss

  • Sold in 53 states
  • Sold at Medtronic MiniMed, Inc., Authorized Medical Device Distributors
  • Patient reports indicate low battery alerts occurred much shorter than the expected 10-hour buffer, leading to device shut off; early battery depletion can result in power loss, hyperglycemia, and DKA.
Recalled
Added
Dexcom
Critical RiskFDA Device

Dexcom G7 and Dexcom ONE+ CGM Apps Recalled for Failure to Alert

  • Distributed nationwide
  • Sold at Authorized CGM distributors, Apple App Store +1 more
  • 2,429,443 units affected
Recalled
Added
Maquet Critical Care AB
Critical RiskFDA Device

Maquet Servo-u and Servo-n Ventilators Recalled for Measurement Errors

  • Distributed nationwide
  • Sold at Hospitals, Critical care facilities +1 more
Recalled
Added
CHANGE HEALTHCARE CANADA
Medium RiskFDA Device

Change Healthcare Cardiology Software Recalled for Unexpected Shutdown

  • Sold in 14 states
  • Sold at Hospitals, Healthcare Facilities +1 more
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: IntelliVue Patient Monitors Recalled for Arrhythmia Detection Failure

  • Distributed nationwide
  • Sold at Philips North America, Hospital supply distributors
Recalled
Added
Nihon Kohden America
Medium RiskFDA Device

Nihon Kohden America Inc: BSM-3000 Series Bedside Monitor Recalled for False SpO2 Alarms

  • Sold in Iowa
  • Sold at Medical facilities
Recalled
Added
SonarMed
Critical RiskFDA Device

SonarMed Inc: SonarMed NEO Airway Sensors Recalled for Failure to Detect Obstructions

  • Sold in 19 states
  • Sold at Hospital suppliers, Medical device distributors
Recalled
Added
RAYSEARCH LABORATORIES AB
Medium RiskFDA Device

RAYSEARCH LABORATORIES AB: RayStation Radiation Therapy Planning Systems Recalled for Incorrect SSD Reports

  • Distributed nationwide
  • Sold at Authorized distributors
Recalled
Added
GE Healthcare Finland Oy
Medium RiskFDA Device

GE Healthcare Finland Oy: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

  • 25,461 units affected
Recalled
Added
Nihon Kohden America
Medium RiskFDA Device

Nihon Kohden SpO2 Sensors Recalled for Lack of FDA Approval

  • Sold in 29 states
  • Sold at Nihon Kohden America Inc
Recalled
Added