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
Edwards Lifesciences
Medium RiskFDA Device

Edwards Lifesciences, LLC: Pressure Monitoring Kits and Sensors Recalled for Flushing Difficulties

  • Sold in 51 states
  • Sold at Authorized medical distributors, Direct hospital sales
  • 339,114 units affected
Recalled
Added
EMPATICA SRL
Medium RiskFDA Device

EMPATICA SRL: Embrace2 Seizure Monitoring Devices Recalled for Shortened Battery Life

  • Distributed nationwide
  • Sold at Direct from Manufacturer, Healthcare facilities
Recalled
Added
C.R. Bard
Medium RiskFDA Device

C.R. Bard Inc: Foley Catheter Tray Systems Recalled for Incorrect Temperature Readings

  • Distributed nationwide
  • Sold at medical distributors, healthcare facilities
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: IntelliVue G7m Anesthesia Gas Modules Recalled Due to Pump Failure Risk

  • Distributed nationwide
  • Sold at Philips North America, Medical equipment distributors
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Patient Information Center iX Recalled for Software Notification Error

  • Distributed nationwide
  • Sold at Authorized medical equipment distributors, Direct sales to healthcare facilities
Recalled
Added
Physio-Control
Medium RiskFDA Device

Physio-Control, Inc.: LIFEPAK 15 Monitor/Defibrillators Recalled for Tooling Inaccuracy

  • Sold in 7 states
  • Sold at Authorized Medical Distributors, Physio-Control, Inc.
Recalled
Added
R A Medical Services
Medium RiskFDA Device

R A Medical Services: MINISCAV Vacuum Pump Recalled for Inadequate Documentation

  • Sold in Ohio
Recalled
Added
Baxter Healthcare
Critical RiskFDA Device

Baxter Healthcare Corporation: Novum IQ Syringe Infusion System Recalled for Alarm and Fluid Delivery Errors

  • Sold in 27 states
  • Sold at Baxter Healthcare Corporation
Recalled
Added
Fresenius Medical Care
Medium RiskFDA Device

Fresenius Medical Care Holdings, Inc.: BPM3 Blood Pressure Modules Recalled for Failure to Record or Alarm

  • Distributed nationwide
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Blood Pressure Units Recalled for Manufacturing Non-Compliance

  • Distributed nationwide
  • 74,339 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Patient Information Center (PIC) iX Power Supply Recalled for Failure Risk

  • Distributed nationwide
  • Sold at Philips North America Llc, Schneider Electric IT Corporation
  • 12,936 units affected
Recalled
Added
Roche Diabetes Care
High RiskFDA Device

Roche Diabetes Care, Inc.: Accu-Chek Guide (SC) Kits Recalled for Incorrect Measurement Units

  • Distributed nationwide
  • Three consumer complaints regarding incorrect units of measure; no specific injuries detailed.
Recalled
Added
BD SWITZERLAND SARL
Medium RiskFDA Device

BD Connecta Luer-Lok Stopcocks Recalled for Incorrect Instructions

  • Sold in 35 states
  • Sold at Medical supply distributors
Recalled
Added
Thoratec
High RiskFDA Device

Thoratec LLC: HeartMate 3 System Controllers Recalled for Potential Fluid Ingress and Failure

  • Sold in 42 states
  • Sold at Authorized Medical Distributors, Hospitals +1 more
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Sentinel V11 Cardiology Management System Recalled for Data Assignment Error

  • Sold in Minnesota
  • Sold at Clinical and hospital cardiology departments, Medical facility distributors
Recalled
Added
Datascope
Medium RiskFDA Device

Datascope Corp.: Cardiosave Intra-Aortic Balloon Pumps Recalled for Fiber Optic Sensor Failure

  • Distributed nationwide
  • Sold at Direct distribution to hospitals and medical facilities
Recalled
Added
BIGFOOT BIOMEDICAL
High RiskFDA Device

Bigfoot Unity Diabetes Management System Recalled for Software Issue

  • Sold in 9 states
  • Sold at Direct distribution
Recalled
Added
Maquet Medical Systems USA
Critical RiskFDA Device

Maquet Medical Systems USA: CARDIOHELP Emergency Drive Recalled for Possible Blocking or Impairment

  • Sold in 17 states
  • Sold at Maquet Medical Systems USA
Recalled
Added
Braemar Manufacturing
Critical RiskFDA Device

Braemar Monitoring Service Application (MSA) Recalled for Cardiac Data Loss

  • Distributed nationwide
  • Sold at Medical facilities, Healthcare providers +1 more
  • 130,000 units affected
Recalled
Added
ICU Medical
Medium RiskFDA Device

ICU Medical Plum Duo and Plum Solos Infusion Pumps Recalled for Software Issue

  • Distributed nationwide
  • Sold at ICU Medical, Inc.
Recalled
Added
Low RiskFDA Device

FloPatch FP120 Flowmeter Patches Recalled for Incorrect Expiry Date

  • Sold in California
  • Sold at Medical device distributors
Recalled
Added
Fresenius Kabi USA
Medium RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Software Recalled for Extended Start-up Delay

  • Sold in New Jersey, Wisconsin
  • Sold at hospitals, outpatient care environments
Recalled
Added
LivaNova Deutschland
Medium RiskFDA Device

LivaNova Deutschland GmbH: 3T Heater Cooler System Recalled for Incorrect Maintenance Instructions

  • Sold in 11 states
  • Sold at Medical facilities, Authorized distributors
Recalled
Added
Merge Healthcare
Medium RiskFDA Device

Merge Hemo Systems Recalled Due to High-Pressure Blood Pressure Sensor Defect

  • Sold in 17 states
  • Sold at Authorized medical distributors, Direct from manufacturer
Recalled
Added