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
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
CareFusion 303
High RiskFDA Device

BD Alaris Pump Modules Recalled for Over-Infusion Risk Due to Manual Error

  • Sold in 51 states
  • Sold at Direct Sales
  • 242,098 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Patient Information Center iX Recalled for Software Crash and Blank Screen

  • Distributed nationwide
  • Sold at Philips direct sales, Authorized medical device distributors
Recalled
Added
C.R. Bard
Medium RiskFDA Device

C.R. Bard Inc: Bard Nasogastric Sump Tubes and Connectors Recalled for Reduced Suction

  • Distributed nationwide
  • Sold at Hospital suppliers, Medical device distributors
  • 644,496 units affected
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Pyxis MedBank Cabinets Recalled for Incorrect Medication Bin Labels

  • Sold in 41 states
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic SmartSync Patient Connectors Recalled for Abort Button Failure

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Medtronic Sales Representatives
  • 22,091 units affected
Recalled
Added
Medium RiskFDA Device

Stryker Sustainability Solutions: Disposable 5 Lead ECG Cable Systems Recalled for Reprocessing Issues

  • Sold in 12 states
  • Sold at Stryker Sustainability Solutions
  • 38,850 units affected
Recalled
Added
Datascope
Critical RiskFDA Device

Datascope Corp.: Cardiosave Intra-Aortic Balloon Pumps Recalled for Software Correction

  • Distributed nationwide
Recalled
Added
DATEX--OHMEDA
Critical RiskFDA Device

DATEX--OHMEDA, INC.: Giraffe OmniBed Incubators Recalled Due to Loose Warmer Heater Door Screws

  • Distributed nationwide
  • Sold at GE HealthCare authorized distributors
Recalled
Added
SUREPULSE MEDICAL
Low RiskFDA Device

Surepulse VS Cap Recalled for Incorrect Sizing Guide

  • Sold in Connecticut, Texas
  • Sold at Hospital suppliers, Medical device distributors
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs Eclipse PRO and Mini Holter Recorders Recalled for Serial Number Errors

  • Sold in 22 states
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • 14,981 units affected
Recalled
Added
Draeger
Critical RiskFDA Device

Draeger SafeStar and TwinStar Breathing Filters Recalled for Faulty CO2 Monitoring

  • Sold in 30 states
  • Sold at Medical distributors, Direct hospital sales
  • 11,949,459 units affected
Recalled
Added
Visgeneer
Medium RiskFDA Device

Visgeneer Blood Uric Acid Monitoring Systems Recalled for No FDA Clearance

  • Sold in California, Michigan
  • Sold at Nationwide distributors
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Patient Information Center iX Software Recalled for Data Transfer Failure

  • Sold in 18 states
  • Sold at Authorized Philips medical device distributors, Direct clinical sales
Recalled
Added
Oridion Medical 1987
High RiskFDA Device

Microstream CO2 Sampling Lines and Airway Adapters Recalled for Detachment Risk

  • Sold in 51 states
  • Sold at Authorized Medical Distributors, Hospital Suppliers
  • 14,700,798 units affected
Recalled
Added
Abbott Diabetes Care
Critical RiskFDA Device

Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Sensors Recalled for Erroneously High Glucose Readings

  • Sold in 12 states
  • Sold at authorized medical supply distributors, pharmacies
Recalled
Added
Medium RiskFDA Device

Philips Tempus Pro Patient Monitors Recalled for Software Freezes

  • Sold in 43 states
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Sophysa S.A.
Medium RiskFDA Device

Sophysa S.A.: Pressio Ventricular Monitoring Kits Recalled for Catheter Leakage

  • Sold in Arizona, New York, Texas
  • Sold at Authorized Medical Distributors, Hospitals
Recalled
Added
Medtronic MiniMed
Medium RiskFDA Device

Medtronic Simplera Sensor Recalled for Sterility Issues and Infection Risk

  • Sold at authorized dealers
Recalled
Added
NOXBOX
Critical RiskFDA Device

NOxBOXi Nitric Oxide Delivery System Recalled for Dose Fluctuations

  • Sold in Tennessee
  • Sold at Linde, NBL
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Microstream CO2 Filter Lines Recalled for Disconnection Issues

  • Distributed nationwide
  • Sold at Hospital supply distributors, Medical device retailers
  • 486,631 units affected
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed, Inc.: Automated Impella Controller (AIC) Recalled for Heart Pump Detection Failure

  • Distributed nationwide
  • Sold at Hospitals, Specialty Healthcare Facilities
  • Critical risk reported; no specific injury count provided in dataset.
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien: Invos Sensor Cables Recalled for Connector Defects and System Errors

  • Sold in 25 states
  • Sold at Medical distributors, Covidien direct sales
Recalled
Added