Go Backs

Monitoring Devices

AllImplants & Prosthetics(226)Monitoring Devices(263)Diagnostic Equipment(818)Home Healthcare(223)Contact Lenses & Vision(17)Surgical Equipment(895)

263 recalls

per page
Medtronic MiniMed
Medium RiskFDA Device

Medtronic MiniMed 780G Insulin Pumps Recalled for Software Issue

  • Sold in 45 states
  • Sold at Authorized distributors
Recalled
Added
Medium RiskFDA Device

GE Medical Systems Information Technologies Inc: Prucka 3 Amplifiers Recalled Due to Power Failure and Overheating Risk

  • Sold in 17 states
  • Sold at GE Medical Systems Information Technologies Inc, Government distribution
Recalled
Added
Zyno Medical
Medium RiskFDA Device

Zyno Medical LLC: Z-800WF Infusion Pumps Recalled Due to Alarm Software Defect

  • Distributed nationwide
  • Sold at Healthcare facilities, Hospitals +1 more
Recalled
Added
Maquet Medical Systems USA
High RiskFDA Device

Maquet Medical Systems USA: Venous Probe Connection Cables Recalled for Electrical Failures

  • Distributed nationwide
  • Sold at Authorized medical distributors
Recalled
Added
Boston Scientific
Medium RiskFDA Device

Boston Scientific Corporation: ZOOM LATITUDE Programmer Software Recalled for Incorrect Diagnostic Dates

  • Distributed nationwide
  • Sold at Government distribution, Military distribution +1 more
  • 14,328 units affected
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien: Puritan Bennett Cuff Pressure Manager Recalled for Power Inlet Port Failure

  • Sold in 16 states
  • Sold at Authorized medical distributors, Direct medical sales
Recalled
Added
Medium RiskFDA Device

Terumo CDI OneView Monitoring Probes Recalled for Incorrect Data Display

  • Sold in 6 states
  • Sold at Terumo Cardiovascular Systems Corporation, Direct distribution to clinical facilities
Recalled
Added
Turncare
Medium RiskFDA Device

Guardian System 2 Controller Recalled for Software Alert Failures

  • Sold in 5 states
  • Sold at Specialty medical distributors
Recalled
Added
Ambu
Medium RiskFDA Device

Ambu Inc.: Ambu aView 2 Advance Monitors Recalled Due to Fire and Burn Hazards

  • Distributed nationwide
  • Sold at Ambu Inc., Medical device distributors
  • 11,845 units affected
Recalled
Added
Securitas Healthcare
Medium RiskFDA Device

Securitas Healthcare LLC: Arial Mobile App Recalled for Frequent Restarts on iOS 17.4 and 17.5

  • Distributed nationwide
  • Sold at Securitas Healthcare LLC
Recalled
Added
Baxter Healthcare
Critical RiskFDA Device

Welch Allyn Life2000 Ventilators and Compressors Recalled for Cybersecurity Risks

  • Distributed nationwide
  • Sold at Authorized medical distributors, Baxter Healthcare Corporation
Recalled
Added
Medium RiskFDA Device

Philips Tempus Pro Monitors and IBP Modules Recalled for Accuracy Issues

  • Sold in 42 states
  • Sold at Authorized Medical Device Distributors, Direct Hospital Sales
Recalled
Added
SEER MEDICAL PTY
Medium RiskFDA Device

SEER MEDICAL PTY LTD: Seer Home EEG Systems Recalled for EMI Compliance and Labeling Issues

  • Sold in Minnesota, New York, Pennsylvania
  • Sold at Authorized Medical Distributors, Seer Medical
Recalled
Added
Abbott Diabetes Care
Critical RiskFDA Device

Abbott Diabetes Care, Inc.: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

  • 2,990,939 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: Patient Monitoring Software Recalled for Silenced Notification Alarms

  • Distributed nationwide
  • Sold at Philips North America, Direct medical distribution
  • 259,506 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: DIVA Widescreen Touch Displays Recalled Due to Potential Alarm Failures

  • Sold in 10 states
  • Sold at Authorized Philips medical equipment distributors
Recalled
Added
Dexcom
Critical RiskFDA Device

Dexcom G6 Android App Recalled for Software Defect Disabling Glucose Alerts

  • Distributed nationwide
Recalled
Added
Mc3
High RiskFDA Device

Mc3 Inc: Nautilus ECMO Oxygenator and Modules Recalled for Heat Exchange Failure

  • Distributed nationwide
  • Sold at Mc3 Inc
Recalled
Added
Zyno Medical
Critical RiskFDA Device

Zyno Medical LLC: Z-800 Infusion Systems Recalled for Air-In-Line Software Defect

  • Distributed nationwide
  • 34,994 units affected
Recalled
Added
Barco N.V.
Medium RiskFDA Device

Barco N.V.: MDSC-8527 NXF Surgical Display Recalled for Blocked MNA Decoder Functionality

  • Sold in New Jersey
  • Sold at Authorized medical device distributors
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Healthcare Corporation: Spectrum Wireless Battery Modules Recalled for EMR Data Sync Failure

  • Distributed nationwide
  • Sold at Baxter Healthcare Corporation
  • 17,377 units affected
Recalled
Added
Medium RiskFDA Device

Mindray BeneVision N1 Patient Monitors Recalled for Abnormal Alarm Pause

  • Distributed nationwide
  • Sold at Mindray North America, Authorized Medical Distributors +1 more
Recalled
Added
Abbott Medical
Low RiskFDA Device

Abbott Medical: Merlin@home Transmitters Recalled for Software Upgrade Failure

  • Sold in 29 states
  • Sold at Authorized Medical Distributors, Hospitals +1 more
Recalled
Added
St. Jude Medical
Medium RiskFDA Device

St. Jude Medical Merlin.net Heart Failure App Recalled for Transmission Issues

  • Sold in 13 states
  • Sold at Hospitals, Specialized healthcare providers
Recalled
Added