Go Backs

Monitoring Devices

AllImplants & Prosthetics(225)Monitoring Devices(272)Diagnostic Equipment(819)Home Healthcare(232)Contact Lenses & Vision(17)Surgical Equipment(890)

272 recalls

per page
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs SL Command Module Recalled for Electrical Safety Issue

  • Sold in 7 states
  • Sold at Direct distribution to hospitals/clinics
Recalled
Added
Boston Scientific
Medium RiskFDA Device

Boston Scientific LUX-Dx ICM Devices Recalled for Monitoring Failure

  • Distributed nationwide
  • Sold at Direct from manufacturer, Hospitals +1 more
Recalled
Added
North American Rescue
Critical RiskFDA Device

North American Rescue AIDBAGs Recalled for Faulty Glucose Meter Software

  • Sold in California, Washington
  • Sold at specialty first aid kit providers
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs Multi-parameter Command Modules Recalled for Inaccurate Readings

  • Sold in 30 states
  • Sold at Authorized Spacelabs Medical Distributors
Recalled
Added
Abbott Diabetes Care
Medium RiskFDA Device

Abbott Diabetes Care, Inc.: FreeStyle Libre 3 App Recalled for Potential Signal Loss on Android 13

  • Sold in 19 states
  • Sold at Authorized medical distributors, App stores
  • 45,173 units affected
Recalled
Added
Abiomed
Medium RiskFDA Device

Abiomed, Inc.: Automated Impella Controller Recalled for Software Issue and Connection Failure

  • Sold in 5 states
  • Sold at Abiomed, Inc.
Recalled
Added
Abiomed
Medium RiskFDA Device

Abiomed, Inc.: Automated Impella Controller (AIC) Software Update for Pump Recognition Issue

  • Distributed nationwide
  • Sold at Hospitals, Medical Facilities
Recalled
Added
Fresenius Kabi USA
Medium RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Software Recalled for Fail-Stop Alarm Defect

  • Sold in Wisconsin, New Jersey
  • Sold at Specialty medical distributors
Recalled
Added
Hospira
Medium RiskFDA Vet

Hospira Inc.: Plum A+ Infusion System Recalled for Potential Sensor Pin Breakage

  • Sold in 19 states
  • Sold at Medical facilities, Authorized distributors
Recalled
Added
Murata Vios
Medium RiskFDA Device

Murata Vios Monitoring System Recalled for Display Distortion and Flickering

  • Sold in New York, Louisiana
  • Sold at Direct distribution
Recalled
Added
Barco N.V.
Medium RiskFDA Device

Barco N.V.: MNA-420 ENC HDMI Video Encoder Recalled Due to Video Loss Risk

  • Sold in Florida
  • Sold at Authorized Medical Distributors
Recalled
Added
Landauer
Medium RiskFDA Device

Landauer: microSTARii Readers Recalled Due to Dosimeter Measurement Inaccuracies

  • Distributed nationwide
  • Sold at Direct distribution
Recalled
Added
Landauer
Medium RiskFDA Device

Landauer: nanoDot Radiation Dosimeters Recalled for Accuracy Issues

  • Distributed nationwide
  • Sold at Landauer, authorized medical device distributors
  • 1,678,258 units affected
Recalled
Added
DATEX--OHMEDA
Critical RiskFDA Device

DATEX--OHMEDA, INC.: Giraffe Incubators and Omnibeds Recalled for Formaldehyde Exposure

  • Distributed nationwide
  • Sold at Hospital supply channels, Direct medical distribution
  • Formaldehyde contamination
Recalled
Added
Percussionaire
Medium RiskFDA Device

Percussionaire Corporation: Monitron II Waveform Analyzers Recalled for Screen Freeze Malfunction

  • Sold in 4 states
  • Sold at Percussionaire Corporation
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic Inc.: SynchroMed Model A10 Recalled for Software Programming Guidance Error

  • Sold at Hospitals, Specialty medical providers
Recalled
Added
Smiths Medical PM
Medium RiskFDA Vet

Smiths Medical PM, Inc.: Surgivet Advisor Vital Signs Monitor Recalled for Mounting Bracket Failure

  • Sold in 28 states
  • Sold at Medical equipment distributors
Recalled
Added
Hospira
Medium RiskFDA Vet

Hospira Inc.: Plum A+ Infusion System Recalled for Potential Therapy Interruption

  • Sold in 19 states
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
Recalled
Added
Smiths Medical PM
Medium RiskFDA Vet

Smiths Medical PM, Inc.: SurgiVet V6004 NIBP Monitor Recalled for Sudden Power Loss

  • Sold in 6 states
  • Sold at Smiths Medical PM, Inc.
Recalled
Added
Smiths Medical ASD
Low RiskFDA Vet

Smiths Medical ASD Inc.: SurgiVet Advisor Monitor Vital Signs Monitor Systems Recalled for Printing Failure

  • Sold in 21 states
  • Sold at military distribution
Recalled
Added
Hospira
Medium RiskFDA Vet

Hospira Inc.: Plum A+ and A+3 Infusion Pumps Recalled for Roller Assembly Breakage

  • Sold in 19 states
  • Sold at hospitals, healthcare facilities
Recalled
Added
Ge Healthcare
High RiskFDA Vet

Ge Healthcare, Llc: TruSat Pulse Oximeter Recalled for Electrical Current Leak and Burn Risk

  • Sold in 8 states
  • Sold at GE Healthcare authorized distributors
Recalled
Added
Carefusion 2200
Medium RiskFDA Vet

Carefusion 2200 Inc: AirLife Heated Infant Breathing Circuits Recalled for Material Safety Risk

  • Sold in 18 states
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • 318,280 units affected
Recalled
Added
Hospira
Medium RiskFDA Vet

Hospira Inc.: Plum A+ Infusion Pumps Recalled for Pressure Sensor Calibration Errors

  • Sold in 19 states
  • Sold at hospitals, healthcare facilities
Recalled
Added