Go Backs

Monitoring Devices

AllImplants & Prosthetics(226)Monitoring Devices(265)Diagnostic Equipment(820)Home Healthcare(226)Contact Lenses & Vision(17)Surgical Equipment(892)

265 recalls

per page
Nihon Kohden America
Medium RiskFDA Device

Nihon Kohden America Inc: Nihon Kohden SpO2 Sensors Recalled for Lack of FDA Approval

  • Sold in 29 states
  • Sold at Nihon Kohden America Inc
Recalled
Added
Medivance
Medium RiskFDA Device

Medivance Inc.: Neonatal ArcticGel Pads Recalled for Reduced Water Flow and Cooling Failure

  • Sold in 42 states
  • Sold at Direct distribution to hospitals and medical facilities
Recalled
Added
Fresenius Medical Care
High RiskFDA Device

Fresenius Medical Care Holdings, Inc.: Novalung Sensor Box Recalled for Potential Flow Measurement Technical Failure

  • Distributed nationwide
  • Sold at hospitals, specialized medical facilities
Recalled
Added
Medium RiskFDA Device

Mindray BeneVision DMS Recalled for Screen Freezing and Audio Failure

  • Distributed nationwide
  • Sold at Mindray North America, Authorized Medical Device Distributors
Recalled
Added
B Braun Medical
High RiskFDA Device

B Braun Medical Inc: Perfusor Space Syringe Pumps Recalled for Monoject Syringe Incompatibility

  • Distributed nationwide
  • Sold at B Braun Medical Inc, authorized medical distributors
  • 32,004 units affected
Recalled
Added
Medium RiskFDA Device

OBM Digital Acquisition Box Recalled Due to Backwards Labels

  • Distributed nationwide
  • Sold at hospital suppliers, medical equipment distributors
Recalled
Added
Fresenius Kabi USA
Critical RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Software Recalled for Pump and Screen Failures

  • Distributed nationwide
  • Sold at hospital systems, medical distributors
  • Potential for serious patient harm or death; no specific injury counts provided in the notice.
Recalled
Added
Maquet Medical Systems USA
Medium RiskFDA Device

Maquet Medical Systems USA: Cardiohelp-i and Slide Rail Holder Recalled for Faulty Fixation Weld

  • Distributed nationwide
  • Sold at Maquet Medical Systems USA
Recalled
Added
Smiths Medical ASD
Medium RiskFDA Device

Smiths Medical ASD, Inc.: Medex TranStar Disposable Pressure Transducers Recalled for Monitoring Failure

  • Distributed nationwide
  • Sold at authorized medical distributors, specialty healthcare suppliers
  • 1,197,300 units affected
Recalled
Added
Insulet
Critical RiskFDA Device

Insulet Corporation: Omnipod 5 App Recalled for Insulin Over-Delivery Risk

  • Distributed nationwide
  • Sold at Google Play, Authorized distributors
  • 27,000 units affected
Recalled
Added
Baxter Healthcare
High RiskFDA Device

Welch Allyn Medical Monitors and Equipment Recalled for Battery Fire Risk

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Baxter Healthcare Corporation
  • Customer reports of devices experiencing battery-related fires; specific injury counts not provided in initial notice.
Recalled
Added
High RiskFDA Device

Mindray DS USA, Inc. dba Mindray North America: V90 Electronic Vaporizers Recalled for Excessive Anesthetic Output

  • Sold in 8 states
  • Sold at Direct distribution, Medical device distributors
Recalled
Added
B Braun Medical Inc: Streamline Hemodialysis Bloodlines Recalled for Potential Blood Flow Blockage
Medium RiskFDA Device

B Braun Medical Inc: Streamline Hemodialysis Bloodlines Recalled for Potential Blood Flow Blockage

  • Distributed nationwide
  • Sold at B Braun Medical Inc, Direct distribution to hospitals and dialysis centers
  • 43,604,800 units affected
Recalled
Added
Smiths Medical ASD
Critical RiskFDA Device

Smiths Medical ASD Inc.: Medfusion 3500 Syringe Pumps Recalled for Software-Related Delivery Failures

  • Distributed nationwide
  • Sold at authorized dealers, medical supply distributors
  • 93,177 units affected
Recalled
Added
ZOLL Medical
Medium RiskFDA Device

ZOLL Medical Corporation: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  • 141,166 units affected
Recalled
Added
SonarMed
Critical RiskFDA Device

SonarMed Inc: SonarMed Monitor Recalled Due to Software Failure to Detect Airway Obstructions

  • Sold in 19 states
  • Sold at Hospitals, Medical facilities +1 more
Recalled
Added
Datascope
Critical RiskFDA Device

Datascope Corp.: Cardiosave Intra-Aortic Balloon Pumps Recalled for False Gas Alarms

  • Distributed nationwide
  • Sold at Hospital suppliers, Medical device distributors
Recalled
Added
Neurovision Medical Products
Medium RiskFDA Device

Neurovision Medical Products Inc: Cobra EMG ET Tube Recalled for Incorrect Size Labeling

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

Welch Allyn SureTemp Plus Thermometer Probes Recalled for Temperature Errors

  • Distributed nationwide
  • Sold at Authorized medical supply dealers, Specialty retailers
Recalled
Added
ICU Medical
Medium RiskFDA Device

LifeShield Infusion Safety Software Suite Recalled for Review Option Failure

  • Sold in 7 states
  • Sold at Direct distribution
Recalled
Added
Datascope
Medium RiskFDA Device

Cardiosave Hybrid and Rescue Balloon Pumps Recalled for Maintenance Update

  • Distributed nationwide
  • Sold at Direct Sales to Hospitals, Medical Device Distributors
  • 11,517 units affected
Recalled
Added
Physio-Control
High RiskFDA Device

Physio-Control, Inc.: LIFEPAK 15 Defibrillators Recalled for Potential Battery Power Failure

  • Sold in 5 states
  • Sold at Authorized Medical Distributors, Direct Sales
Recalled
Added
Masimo
Medium RiskFDA Device

Masimo Corporation: Rad-G Pulse Oximeters Recalled for Unexpected Power Cycles

  • Distributed nationwide
  • Sold at Authorized medical distributors, Specialty healthcare retailers
  • 27,209 units affected
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed Impella RP Devices Recalled for Malfunctioning Pressure Sensors

  • Distributed nationwide
  • Sold at Direct medical distribution
Recalled
Added