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
Datascope
Medium RiskFDA Device

Datascope CS100 and CS300 IABP Recalled for Incorrect Battery Specifications

  • Distributed nationwide
  • Sold at Direct distribution to hospitals and healthcare facilities
  • 10,897 units affected
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed Automated Impella Controller Recalled for Purge Pressure Issues

  • Distributed nationwide
  • Sold at Hospitals, Medical centers +1 more
Recalled
Added
Smiths Medical ASD
High RiskFDA Device

CAPNOCHECK Airway Adapters Recalled for Risk of Breakage and Ventilation Loss

  • Distributed nationwide
  • Sold at Specialty medical equipment distributors, Healthcare facilities +1 more
  • 175,994 units affected
Recalled
Added
Draeger Medical Systems
Medium RiskFDA Device

Infinity Central Station Speakers Recalled Due to Alarm Failure

  • Sold in 22 states
  • Sold at Draeger Medical Systems, Inc.
Recalled
Added
Maquet Medical Systems USA
Medium RiskFDA Device

Maquet Medical Systems USA: CARDIOHELP-i Recalled Due to Incorrect Settings in Instructions for Use

  • Distributed nationwide
  • Sold at Authorized medical distributors
Recalled
Added
GE Medical Systems
Medium RiskFDA Device

GE Medical Systems, LLC: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

  • 29,225 units affected
Recalled
Added
Draeger Medical Systems
High RiskFDA Device

Draeger Medical Systems, Inc.: Infinity Monitoring Systems Recalled Due to Electric Shock Risk

  • Distributed nationwide
  • Sold at authorized medical distributors, direct sales to healthcare facilities
  • 34,102 units affected
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Pyxis Dispensing Cabinets Recalled for Software-Induced Medication Delays

  • Sold in 34 states
  • Sold at Direct sales to hospitals and healthcare facilities
Recalled
Added
Murata Vios
Medium RiskFDA Device

Murata Vios Bedside Monitors Recalled for Incorrect Sensor Warning

  • Sold in New York
  • Sold at Authorized medical distributors
Recalled
Added
Spectrum Medical
Medium RiskFDA Device

Quantum Informatics VIPER and VISION Software Recalled for No FDA Clearance

  • Sold in 41 states
  • Sold at Direct to hospitals and clinical facilities
Recalled
Added
Datascope
Critical RiskFDA Device

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

  • Distributed nationwide
  • Sold at Hospitals, Healthcare facilities +1 more
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Alaris System Manager Recalled Due to Server Connection Software Issue

  • Sold in 45 states
  • Sold at Medical facilities, Direct distribution
Recalled
Added
Maquet Medical Systems USA
Medium RiskFDA Device

Maquet Medical Systems USA: Bubble Sensor Recalled for Incorrect Universal Device Identifier (UDI) Labeling

  • Sold in 13 states
  • Sold at Maquet Medical Systems USA
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic Inc.: Medtronic CareLink 2090 Programmers Recalled for Autonomous Cursor Motion

  • Distributed nationwide
  • Sold at Medtronic Inc., Authorized Medical Distributors
  • 18,788 units affected
Recalled
Added
Defibtech
Critical RiskFDA Device

Defibtech, LLC: RMU-2000 Automated Chest Compression Device Recalled for Motor Failure

  • Sold in 5 states
  • Sold at Defibtech authorized distributors, medical supply channels
  • Potential for patient injury or death due to failure to operate; no specific incident counts provided.
Recalled
Added
Datascope
Critical RiskFDA Device

Datascope Corp.: Cardiosave Intra-Aortic Balloon Pumps Recalled for Autofill Failure Risks

  • Distributed nationwide
  • Sold at Direct sales, Medical device distributors
Recalled
Added
Verathon
Medium RiskFDA Device

Verathon, Inc.: GlideScope Core Monitors Recalled Due to Potential Image Loss or Degradation

  • Sold in 49 states
  • Sold at Authorized medical device distributors
Recalled
Added
GE Medical Systems China
Medium RiskFDA Device

GE Medical Systems China Co., Ltd.: F2-01 Frame Recalled for Data Communication Interruption

  • Distributed nationwide
  • Sold at GE Medical Systems China Co., Ltd., National Hi-Tech
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: IntelliVue Patient Monitors Recalled for Incorrect Software Options

  • Distributed nationwide
  • Sold at Philips North America Llc, Medical Equipment Distributors
Recalled
Added
Medtronic Perfusion Systems
Medium RiskFDA Device

Medtronic VitalFlow Consoles Recalled for Touch Screen Display Error

  • Distributed nationwide
  • Sold at Hospitals, Medical Facilities +1 more
  • 11 reports of the E70 error code occurring during operation; no patient injuries or deaths specifically reported.
Recalled
Added
Zoe Medical
Medium RiskFDA Device

Zoe Medical Incorporated: Vital Signs Monitors Recalled Due to Inadequate Battery Warning Labels

  • Distributed nationwide
  • Sold at Zoe Medical Incorporated, Healthcare facilities
Recalled
Added
Medtronic Neuromodulation
Medium RiskFDA Device

Medtronic Neuromodulation: InterStim Smart Programmer Kits Recalled for Pairing Failure

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospitals +1 more
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter Healthcare Corporation: Welch Allyn Connex Spot Monitor Recalled for Improper Display Assembly

  • Sold in California
  • Sold at Authorized medical distributors
Recalled
Added
PYRAMES
Medium RiskFDA Device

Boppli Blood Pressure Monitors Recalled for Detection Failures

  • Sold in Massachusetts, California
  • Sold at Direct to hospitals, Authorized clinical distributors
Recalled
Added