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
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Anti-TG Ab Recalled for Falsely Elevated Test Results

  • Sold in 23 states
  • Sold at Clinical Laboratories, Hospitals
Recalled
Added
Medium RiskFDA Device

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper Fluoroscopic X-ray Systems Recalled for Imaging Failure Risk

  • Sold in 49 states
  • Sold at Direct medical distribution, Authorized medical equipment dealers
Recalled
Added
Medium RiskFDA Device

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: MyoSPECT Systems Recalled Due to Risk of Falling Lead Covers and Injury

  • Sold in 27 states
  • Sold at Authorized GE Healthcare distributors, Direct medical equipment sales
  • Lead (Pb) contamination
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Atellica CH Immunoglobulin M_2 (IgM_2) Reagent Recalled for Negative Bias Risk

  • Sold in 41 states
  • Sold at Clinical laboratories, Hospitals +1 more
Recalled
Added
Cook
Critical RiskFDA Device

Cook Beacon Tip Angiographic Catheters Recalled for Potential Tip Separation

  • Distributed nationwide
  • Sold at hospitals, medical supply distributors
  • 26,986 units affected
Recalled
Added
C-RAD POSITIONING AB
Medium RiskFDA Device

Catalyst and Catalyst+ Radiotherapy Systems Recalled for Positioning Errors

  • Sold in 18 states
  • Sold at Hospitals, Radiotherapy centers +1 more
Recalled
Added
Blue Ortho
Medium RiskFDA Device

Blue Ortho Predict+ Software Recalled for Lack of FDA Clearance

  • Distributed nationwide
  • Sold at Blue Ortho, Direct distribution
Recalled
Added
Medium RiskFDA Device

Siemens Atellica CH UCFP Assay Recalled for Potential Inaccurate Results

  • Distributed nationwide
  • Sold at Authorized distributors, Hospitals +1 more
  • 11,811 units affected
Recalled
Added
Beckman Coulter Ireland
Medium RiskFDA Device

Beckman Coulter LDL Cholesterol Reagent Recalled for Inaccurate Results

  • Sold in 52 states
  • Sold at Clinical Laboratories, Hospitals +1 more
  • 34,451 units affected
Recalled
Added
Medium RiskFDA Device

Philips Azurion 7M20 FlexArm Systems Recalled for Stand Movement Issues

  • Sold in 28 states
  • Sold at Authorized medical equipment distributors, Direct hospital sales
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter DxI 9000 Analyzers Recalled for Software Failure

  • Distributed nationwide
  • Sold at Beckman Coulter, Inc., Medical laboratories +1 more
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Access Thyroglobulin Assay Recalled for Erroneously High Results

  • Distributed nationwide
  • Sold at Beckman Coulter authorized distributors, Direct laboratory sales
Recalled
Added
Maquet Cardiopulmonary
Medium RiskFDA Device

Maquet Bubble Sensor Recalled for Cable Durability and Connection Errors

  • Distributed nationwide
  • Sold at Direct from manufacturer, Medical distributors
Recalled
Added
FUJIFILM Healthcare Americas
Medium RiskFDA Device

FUJIFILM FDR Visionary Suite CH-200 Recalled for Support Shaft Breakage Risk

  • Sold in 8 states
  • Sold at Authorized Medical Equipment Distributors
Recalled
Added
Microbiologics
Low RiskFDA Device

Microbiologics Inc: KWIK-STIK ANA (3 Strains) QC Set Recalled for Missing Strain

  • Sold in 4 states
  • Sold at Direct distribution to laboratories
Recalled
Added
Ventana Medical Systems
Medium RiskFDA Device

Ventana Medical Systems, Inc.: Rabbit Monoclonal Antibody Recalled for Potential False Positive Results

  • Sold in 50 states
  • Sold at Medical laboratories, Hospitals +1 more
  • 22,839 units affected
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: FilmArray TORCH Diagnostic Systems Recalled for Power Switch Overheating

  • Sold in 53 states
  • Sold at BioFire Diagnostics, LLC, Medical distributors
Recalled
Added
RAYSEARCH LABORATORIES AB
Medium RiskFDA Device

RAYSEARCH LABORATORIES AB: RayStation and RayPlan Software Recalled for Incorrect Implant Material Settings

  • Distributed nationwide
  • Sold at Direct Sales, Authorized Medical Device Distributors
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

VITROS Ca Slides Recalled for Calibration Failures and Testing Delays

  • Distributed nationwide
  • Sold at Laboratory suppliers, Medical device distributors
  • 174,215 units affected
Recalled
Added
Reflexion Medical
Medium RiskFDA Device

Reflexion Medical, Inc.: RefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Errors

  • Sold in 6 states
  • Sold at Authorized medical distributors
Recalled
Added
Medium RiskFDA Device

Quantimetrix Dipper Urinalysis Dipstick Control Recalled for Temperature Exposure

  • Sold in District of Columbia
  • Sold at McKesson Medical-Surgical Inc.
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS Anti HBs Calibrators Recalled for Positively Biased Results

  • Sold in 31 states
  • Sold at Authorized distributors, Medical supply channels
Recalled
Added
Low RiskFDA Device

Tempus LS-Manual Defibrillators Recalled for Mislabeling Errors

  • Sold in 8 states
  • Sold at Farnborough Aerospace Centre
Recalled
Added
Neurovision Medical Products
Medium RiskFDA Device

Hummingbird Stimulated EMG Kits Recalled for Incorrect Packaging and Contents

  • Sold in California
  • Sold at Specialized medical distributors
Recalled
Added