Go Backs

Monitoring Devices

AllImplants & Prosthetics(226)Monitoring Devices(267)Diagnostic Equipment(820)Home Healthcare(229)Contact Lenses & Vision(17)Surgical Equipment(891)

267 recalls

per page
Medtronic Xomed
Medium RiskFDA Device

NIM Vital Nerve Monitoring System Recalled for Potential Procedure Delays

  • Sold in 53 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Medium RiskFDA Device

GE Medical Systems Information Technologies Inc: Prucka 3 Amplifiers Recalled for ECG Display Failure

  • Sold in 21 states
  • Sold at GE Medical Systems Information Technologies Inc
Recalled
Added
KENT IMAGING
Medium RiskFDA Device

KENT IMAGING, INC.: Snapshot NIR Measurement System Recalled Due to Unresponsive Touchscreens

  • Sold in 12 states
  • Sold at Direct distribution
Recalled
Added
Physio-Control
High RiskFDA Device

LIFEPAK 20e Defibrillator/Monitor Recalled for Incorrect Keypad Installation

  • Sold in West Virginia
Recalled
Added
Physio-Control
Medium RiskFDA Device

Physio-Control LIFEPAK 15 Sensors Recalled for Monitoring Error Messages

  • Sold in 27 states
  • Sold at Physio-Control, Inc. authorized distributors, Direct clinical sales
Recalled
Added
Hamilton Medical AG
Critical RiskFDA Device

Hamilton Medical AG: HAMILTON-C6 Ventilator Recalled for Critical Ventilation Failure Risk

  • Sold in 12 states
  • Sold at Authorized Medical Distributors
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Smart-hopping 2.0 Patient Monitor Recalled for Connection Issues

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct Sales
  • 13,470 units affected
Recalled
Added
Abiomed
Medium RiskFDA Device

Abiomed, Inc.: Impella Connect Software Features Disabled Due to Lack of FDA Evaluation

  • Distributed nationwide
  • Sold at Clinicians, Impella support staff +1 more
Recalled
Added
C.R. Bard
Medium RiskFDA Device

C.R. Bard Inc: Sensica Urine Output System Recalled for Time Display Errors

  • Distributed nationwide
  • Sold at Authorized Medical Distributors
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Healthcare Corporation: Spectrum IQ Infusion Pump Recalled for Improper Testing

  • Sold in Massachusetts
  • Sold at Service Center
Recalled
Added
Draegerwerk Ag & Co. Kgaa
Medium RiskFDA Device

Draegerwerk Ag & Co. Kgaa: Atlan Anesthesia Gas Machines Recalled Due to Battery Failure and Shutdown

  • Distributed nationwide
  • Sold at Draeger, Inc.
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: IntelliVue Patient Monitors Recalled for Loss of Electrical Grounding

  • Distributed nationwide
  • Sold at Global Distribution
Recalled
Added
St. Jude Medical
Medium RiskFDA Device

CardioMEMS HF Systems Recalled for Inaccurate Pressure Readings

  • Sold in 41 states
  • Sold at Hospitals, Specialty Clinics +1 more
Recalled
Added
Medtronic Xomed
Critical RiskFDA Device

Medtronic Xomed, Inc.: NIM Vital Nerve Monitoring System Recalled for Potential False Negatives

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Specialty retailers
Recalled
Added
Ventec Life Systems
Critical RiskFDA Device

VOCSN Multi-Function Ventilators Recalled Due to Servicing Errors

  • Sold in California, New York, Missouri
  • Sold at authorized medical device distributors
Recalled
Added
InfuTronix LLC: Nimbus Infusion Pump Systems Recalled for Multiple Failure Risks
Critical RiskFDA Device

InfuTronix LLC: Nimbus Infusion Pump Systems Recalled for Multiple Failure Risks

  • Distributed nationwide
  • Sold at hospitals, medical clinics +1 more
  • 52,328 units affected
Recalled
Added
Integra LifeSciences
Critical RiskFDA Device

Integra LifeSciences Corp.: CereLink ICP Extension Cables Recalled for Inaccurate Pressure Readings

  • Sold in 30 states
  • Sold at Integra LifeSciences Corp.
Recalled
Added
Securitas Healthcare
Medium RiskFDA Device

Securitas Healthcare LLC: Arial Call Stations Recalled Due to Potential Alarm Failure and Battery Loss

  • Sold in 13 states
Recalled
Added
HeartSine Technologies
Critical RiskFDA Device

HeartSine Technologies Ltd: HeartSine samaritan PAD Defibrillators Recalled for Configuration Error

  • Sold in 7 states
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien Nellcor Bedside Monitoring Systems Recalled for Alarm Failure

  • Sold in 50 states
  • Sold at Authorized Medical Distributors, Direct Sales from Covidien
  • Alarm recognition issues resulting in treatment delay, lack of response to low oxygen, respiratory failure, and arrhythmia.
Recalled
Added
Medtronic MiniMed
High RiskFDA Device

Medtronic MiniMed, Inc.: Guardian 4 Glucose Sensors Recalled for Inaccurate Insulin Delivery Risk

  • Sold in 48 states
  • Sold at Authorized Medtronic Distributors
  • 114,758 units affected
Recalled
Added
Maquet Medical Systems USA
Low RiskFDA Device

Maquet Medical Systems USA: CARDIOHELP-i Heart Lung Support System Recalled for Improper Leakage Testing

  • Distributed nationwide
  • Sold at Authorized medical distributors
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Healthcare Corporation: Spectrum IQ Infusion Pumps Recalled for Potential Front Panel Cracks

  • Sold in Ohio, Wisconsin
  • Sold at Direct distribution
Recalled
Added
Defibtech
Medium RiskFDA Device

Defibtech Automated External Defibrillators Recalled for Missing Instructions

  • Sold at Overseas distributors
Recalled
Added