Go Backs

Monitoring Devices

AllImplants & Prosthetics(227)Monitoring Devices(261)Diagnostic Equipment(819)Home Healthcare(220)Contact Lenses & Vision(17)Surgical Equipment(895)

261 recalls

per page
Medtronic MiniMed
Medium RiskFDA Device

Medtronic InPen App Recalled for Software Errors in Insulin Reminders

  • Distributed nationwide
  • Sold at App Store, Google Play Store +1 more
Recalled
Added
Wipro GE Healthcare Private
Medium RiskFDA Device

GE HealthCare Carescape Central Stations Recalled for Reboot Issue

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Direct medical sales
Recalled
Added
Wipro GE Healthcare Private
Medium RiskFDA Device

Wipro GE Healthcare Private Ltd.: Giraffe and Panda iRes Warmers Recalled for Incomplete Electrical Safety Testing

  • Distributed nationwide
  • Sold at GE HealthCare, authorized medical distributors
Recalled
Added
Datascope
Critical RiskFDA Device

Datascope Corp.: Cardiosave Intra-Aortic Balloon Pumps Recalled for Overheating and Pumping Loss

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • 11,621 units affected
Recalled
Added
Medivance
Medium RiskFDA Device

Medivance Inc.: Arctic Sun Temperature Management Systems Software Update for Alarm Failure

  • Sold in 52 states
  • Sold at Hospitals, Medical facilities +1 more
  • 10,507 units affected
Recalled
Added
Smiths Medical ASD
Critical RiskFDA Device

Smiths Medical ASD Inc.: Medfusion Model 4000 Syringe Pumps Recalled for Critical Software Faults

  • Distributed nationwide
  • Sold at Hospitals, Healthcare facilities
  • 60,146 units affected
Recalled
Added
Schiller, Ag
Medium RiskFDA Device

Argus PB-3000 Vital Sign Monitors Recalled for Blood Pressure Error

  • Sold in Montana, Wisconsin, Illinois
Recalled
Added
Spark Biomedical
Medium RiskFDA Device

Sparrow Ascent Patient Controllers Recalled for Stimulation Interruptions

  • Distributed nationwide
  • Sold at Authorized distributors
Recalled
Added
St. Jude Medical
Medium RiskFDA Device

CardioMEMS Heart Failure System Recalled for Patient Data Issues

  • Sold in 46 states
  • Sold at Treating Clinic, Consulting Clinic
Recalled
Added
Spacelabs Healthcare
High RiskFDA Device

Xhibit Telemetry Receivers Recalled for System Shutdown and Monitoring Loss

  • Sold in 44 states
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Healthcare Corporation: Braun Thermoscan PRO 6000 Recalled for Outdated Instructions for Use

  • Distributed nationwide
  • Sold at medical distributors
  • 265,647 units affected
Recalled
Added
B. Braun Medical
Critical RiskFDA Device

B. Braun Medical, Inc.: Infusomat Large Volume Pumps Recalled for False Upstream Occlusion Alarms

  • Distributed nationwide
  • Sold at Hospitals, Medical facilities
  • Potential for hemodynamic instability, permanent impairment, or death; no specific injury count provided.
Recalled
Added
Medtronic Neurosurgery
Critical RiskFDA Device

Medtronic Becker and Exacta Drainage Systems Recalled for Stopcock Leaks

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospitals
  • Multiple complaints received reporting cracks and/or leaks; exact injury count not specified.
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Smart-Hopping 2.0 Access Points Recalled for Connection and Data Risks

  • Distributed nationwide
  • Sold at Direct to hospitals, Authorized medical distributors
Recalled
Added
CareFusion 303
Critical RiskFDA Device

CareFusion 303, Inc.: Alaris Infusion Pump Modules Recalled for Unvalidated Syringe Compatibility

  • Sold in 54 states
  • Sold at Hospitals, Medical facilities
  • 1,087,482 units affected
Recalled
Added
Murata Vios
Medium RiskFDA Device

Murata Vios Bedside Monitors Recalled for Battery and Connection Issues

  • Sold in 7 states
  • Sold at Authorized medical distributors
Recalled
Added
Securitas Healthcare
Medium RiskFDA Device

Arial Server Software Recalled for Emergency Call Notification Failure

  • Distributed nationwide
  • Sold at Securitas Healthcare LLC
Recalled
Added
IHB OPERATIONS B.V.
Medium RiskFDA Device

Skytron Freedom 4FXS-60 Monitor Mounts Recalled for Falling Hazard

  • Sold in 24 states
  • Sold at Skytron authorized distributors
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Pyxis Automated Dispensing Cabinets Recalled for Electrical Shock Risk

  • Sold in 47 states
  • Sold at Authorized Medical Device Distributors, Direct Hospital Sales
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

  • 348,766 units affected
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed Automated Impella Controllers Recalled for Potential Pump Failure

  • Sold in 17 states
  • Sold at Hospitals, Medical Facilities
Recalled
Added
Omega Medical Imaging
Medium RiskFDA Device

Omega Medical Imaging, Inc.: Elevating Monitor Suspension Recalled for Monitor Detachment Risk

  • Distributed nationwide
  • Sold at authorized distributors
  • One incident where an actuator separated and the monitor was restrained by a safety cable; no injuries reported.
Recalled
Added
Sophysa
Medium RiskFDA Device

Sophysa Pressio 2 ICP Monitoring Systems Recalled for Unexpected Rebooting

  • Sold in 9 states
  • Sold at Authorized medical equipment distributors
Recalled
Added
SenTec AG
Medium RiskFDA Device

SenTec AG: Sentec Digital Monitoring System Components Recalled for Measurement Errors

  • Distributed nationwide
Recalled
Added