Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(227)Monitoring Devices(261)Diagnostic Equipment(819)Home Healthcare(220)Contact Lenses & Vision(17)Surgical Equipment(896)

819 recalls

per page
GE Medical Systems
High RiskFDA Device

GE Optima XR200, XR220, and XR240amx Systems Recalled for Drop Hazard

  • Distributed nationwide
  • Sold at Authorized GE HealthCare medical equipment distributors, Direct medical sales
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Brilliance and Spectral CT Systems Recalled for Rotor Detachment Risk

  • Sold in 24 states
  • Sold at Hospitals, Imaging Centers +1 more
Recalled
Added
Fisher Diagnostics
Medium RiskFDA Device

Fisher Diagnostics Pacific Hemostasis Thromboplastin-D Recalled for Labeling Error

  • Sold in Pennsylvania
  • Sold at Fisher Diagnostics distribution channels
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Access Intact PTH Assay Recalled for Inaccurate Test Results

  • Distributed nationwide
  • Sold at Beckman Coulter, Inc.
Recalled
Added
Agfa Healthcare NV
Medium RiskFDA Device

Agfa Enterprise Imaging XERO Viewer Recalled for Software Imaging Defect

  • Distributed nationwide
  • Sold at Agfa Healthcare NV, Specialty Medical Imaging Retailers +1 more
Recalled
Added
TECHNO-PATH MANUFACTURING
Medium RiskFDA Device

Multichem ID-B Positive Control Recalled for Potential Test Result Errors

  • Sold in 17 states
  • Sold at Laboratory Distributors, Diagnostic Laboratories
Recalled
Added
Abbott Molecular
Medium RiskFDA Device

Abbott Alinity m HPV and STI AMP Kits Recalled for Risk of Invalid Results

  • Sold in 25 states
  • Sold at Hospitals, Diagnostic Laboratories +1 more
  • Iron contamination
Recalled
Added
Cadwell Industries
Medium RiskFDA Device

Cadwell Industries Inc: Cascade IOMAX Cortical Module Recalled for Unintended Electrical Stimulation

  • Sold in Illinois, California
  • Sold at Direct Sales, Medical Distributors
Recalled
Added
Medium RiskFDA Device

Philips Azurion Systems Recalled for Software Imaging and Movement Issues

  • Distributed nationwide
  • Sold at Philips Medical Systems, Authorized medical equipment distributors
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

  • Distributed nationwide
  • Sold at Authorized Beckman Coulter distributors, Direct laboratory sales
Recalled
Added
CareFusion 303
Medium RiskFDA Device

CareFusion 303, Inc.: BD Pyxis MedBank MedPass Software Recalled for Duplicate Medication Risk

  • Sold in Florida, Michigan, Kansas
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
Medium RiskFDA Device

Philips Allura and Azurion Patient Tables Recalled for Finger Entrapment Risk

  • Distributed nationwide
  • Sold at authorized medical device distributors, Philips direct sales
Recalled
Added
Remel
Medium RiskFDA Device

Remel Blood Agar Biplates Recalled for Listeria Contamination

  • Distributed nationwide
  • Sold at Remel, Inc
  • Listeria monocytogenes contamination
Recalled
Added
Universal Meditech Inc.: Various Diagnostic Tests Recalled Due to Lack of Marketing Authorization
Medium RiskFDA Device

Universal Meditech Inc.: Various Diagnostic Tests Recalled Due to Lack of Marketing Authorization

  • Sold in 8 states
  • Sold at Distributors
  • 536,385 units affected
Recalled
Added
NovaSignal
Medium RiskFDA Device

NovaSignal Corp.: NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock and Malfunction Risk

  • Sold in 17 states
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
TECHNO-PATH MANUFACTURING
Medium RiskFDA Device

TECHNO-PATH MANUFACTURING LTD.: Laboratory Control Vials Recalled Due to Risk of Glass Breakage

  • Sold in Illinois
  • Sold at Specialty medical distributors
  • Glass fragments contamination
Recalled
Added
Medium RiskFDA Device

Olympus Corporation of the Americas: Specific Repaired Colonoscopes Recalled for Lack of Protective Adhesive

  • Distributed nationwide
  • Sold at Olympus Corporation of the Americas
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Philips Imaging Systems Recalled Due to Risk of Ceiling Units Falling

  • Distributed nationwide
  • Sold at Authorized Philips medical equipment distributors, Direct medical facility sales
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, INc.: VITROS Chemistry Products ALKP Slides Recalled for Incorrect Test Results

  • Distributed nationwide
  • Sold at Laboratory suppliers, Hospitals +1 more
  • 455,422 units affected
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: FilmArray Gastrointestinal Panel Recalled for False Positive Norovirus Results

  • Sold in 51 states
  • Sold at Medical distributors, Laboratory suppliers +1 more
  • 64,594 units affected
Recalled
Added
Abbott Laboratories
Medium RiskFDA Device

Abbott Laboratories CELL-DYN Ruby Hematology System Recalled for Software Error

  • Sold in 34 states
  • Sold at Authorized Medical Device Distributors, Direct Hospital Sales
Recalled
Added
Medium RiskFDA Device

Siemens AG/Siemens Healthcare GmbH: ARTIS icono Angiography Systems Recalled for Excess Radiation Risk

  • Sold in 12 states
  • Sold at Siemens Healthcare, Medical Equipment Distributors
Recalled
Added
Medium RiskFDA Device

Siemens Magnesium Reagent Cartridges Recalled for Falsely Low Test Results

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Medical laboratory distributors
  • 13,115 units affected
Recalled
Added
ACTIM OY
Medium RiskFDA Device

ACTIM OY: Actim PROM Dipstik Recalled Due to False Positive Test Results

  • Sold in Connecticut
  • Sold at Medical distributors
Recalled
Added