Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(229)Monitoring Devices(255)Diagnostic Equipment(818)Home Healthcare(217)Contact Lenses & Vision(17)Surgical Equipment(896)

818 recalls

per page
Beckman Coulter
Medium RiskFDA Device

CellMek SPS Sample Preparation System Recalled for Software Error

  • Sold in 6 states
  • Sold at Direct sales, Medical distributors
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Solana Bordetella Complete Assay Recalled for False Positive Risks

  • Distributed nationwide
  • Sold at QuidelOrtho, Medical facilities +1 more
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzers Recalled for Software Bug and Result Delays

  • Sold in 12 states
  • Sold at Beckman Coulter, Inc.
Recalled
Added
Micro-X
Medium RiskFDA Device

Rover Mobile X-ray Systems Recalled Due to Internal Generator Failure

  • Sold in New Jersey, Washington, Puerto Rico
  • Sold at Authorized distributors, Medical facilities
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry FS Diluent Pack 3 Recalled for Potential Biased Test Results

  • Sold in 4 states
  • Sold at Laboratory suppliers, Direct medical distribution
Recalled
Added
Hologic
Medium RiskFDA Device

Hologic Inc: Horizon X-Ray Bone Densitometers Recalled for Electromagnetic Safety Standards

  • Distributed nationwide
  • Sold at Hologic Inc authorized distributors, Direct manufacturer sales
Recalled
Added
Critical RiskFDA Device

Philips Azurion Imaging Systems Recalled for X-ray Functionality Issues

  • Distributed nationwide
  • Sold at Hospital equipment suppliers, Direct sales to medical facilities
Recalled
Added
Vero Biotech
Medium RiskFDA Device

Vero Biotech, LLC: GENOSYL DS Generation 3 Cassettes Recalled for Flow Criterion Failure

  • Sold in Arizona, Florida
  • Sold at Specialized medical distributors
Recalled
Added
Abbott Molecular
Medium RiskFDA Device

Abbott Molecular, Inc.: Alinity m HCV AMP Kits Recalled for False Positive Hepatitis C Results

  • Distributed nationwide
  • Sold at Laboratories, Hospitals +1 more
  • Reports of false positive results in patient samples
Recalled
Added
INTELERAD MEDICAL SYSTEMS
Medium RiskFDA Device

IntelePACS Software Recalled Due to Incorrect Diagnosis Risk

  • Sold in 25 states
  • Sold at Hospitals, Imaging Centers +1 more
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics Inc: epoc BGEM Test Cards Recalled for Potentially Inaccurate High Glucose Results

  • Sold in 26 states
  • Sold at Specialty medical distributors, Siemens Healthcare direct sales
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Inc.: IgA Reagent Kits Recalled Due to Performance Specification Failure

  • Sold in 42 states
  • Sold at Medical laboratories, Healthcare facilities
  • 12,850 units affected
Recalled
Added
INTELERAD MEDICAL SYSTEMS
Medium RiskFDA Device

IntelePACS Software Recalled for Bug Causing Clinical Data Loss

  • Sold in 12 states
  • Sold at Hospital networks, Radiology clinics +1 more
Recalled
Added
Diagnostica Stago
Medium RiskFDA Device

STA Liatest Free Protein S Kits Recalled for Inaccurate Test Results

  • Sold in 23 states
  • Sold at Direct distribution to laboratories and healthcare facilities
Recalled
Added
Civco Medical Instruments
Medium RiskFDA Device

BX2 Needle Guide Recalled for Risk of Transducer Cover Breach

  • Distributed nationwide
  • Sold at Authorized medical device distributors
Recalled
Added
Ortho-Clinical Diagnostics
Low RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS Vitamin B12 Range Verifier Recalled for Failure to Meet Required Range

  • Distributed nationwide
  • Sold at Ortho-Clinical Diagnostics, Inc., Direct distribution to laboratories
Recalled
Added
Instrumentation Laboratory
Medium RiskFDA Device

Instrumentation Laboratory Coagulation Reagent Recalled for Microbe Risk

  • Sold in 9 states
  • Sold at Medical distributors, Hospitals +1 more
  • Microbial contamination contamination
Recalled
Added
NeuroLogica
Medium RiskFDA Device

NeuroLogica GM85 Digital Mobile X-ray Systems Recalled for Loosening Bolts

  • Distributed nationwide
  • Sold at Medical facilities, Hospitals
Recalled
Added
Kreatech Biotechnology Bv
Medium RiskFDA Device

Kreatech PapV-16 ISH Probes Recalled for Potential False Test Results

  • Sold in Florida, New York
  • Sold at Medical distributors, Kreatech Biotechnology Bv
Recalled
Added
Ithera Medical
Medium RiskFDA Device

Ithera Medical MSOT Acuity Echo Recalled for Incorrect Laser Safety Distance

  • Distributed nationwide
  • Sold at Authorized Medical Device Channels
Recalled
Added
Sonesta Medical AB
Medium RiskFDA Device

Sonesta 6210 Video Fluoroscopy Tables Recalled for Backrest Drop Risk

  • Sold in New Hampshire
  • Sold at Medical equipment distributors
Recalled
Added
Puritan Medical Products
Medium RiskFDA Device

Puritan Medical Products Company, Llc: HydroFlock Collection Devices Recalled for Mislabeling and Incorrect Product

  • Sold in 20 states
  • Sold at Puritan Medical Products Company, Llc, Worldwide distribution
Recalled
Added
Steris
Medium RiskFDA Device

Barco MNA HexaVue IP Integration Adapters Recalled for Configuration Error

  • Sold in 7 states
  • Sold at Steris Corporation, Authorized Medical Device Distributors
Recalled
Added
Medium RiskFDA Device

Stratus CS Acute Care cTNI TestPak Recalled for False Positive Results

  • Sold in 12 states
  • Sold at Medical laboratories, Hospitals +1 more
Recalled
Added