Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(229)Monitoring Devices(257)Diagnostic Equipment(818)Home Healthcare(218)Contact Lenses & Vision(17)Surgical Equipment(896)

818 recalls

per page
CareFusion 303
Medium RiskFDA Device

BD Pyxis MedBank Dispensing Cabinets Recalled for Software Bug

  • Sold in 51 states
  • Sold at Authorized Medical Distributors, Direct Sales to Hospitals +1 more
Recalled
Added
Beckman Coulter Ireland
Medium RiskFDA Device

Beckman Coulter Bicarbonate Reagents Recalled for Falsely High Results

  • Sold in 52 states
  • Sold at Beckman Coulter Ireland, Inc., Authorized clinical laboratory supply distributors
  • 36,981 units affected
Recalled
Added
Philips Ultrasound, Inc.: 5000 Compact Series Ultrasound Systems Recalled for Patient Burn Risk
Medium RiskFDA Device

Philips Ultrasound, Inc.: 5000 Compact Series Ultrasound Systems Recalled for Patient Burn Risk

  • Sold in 26 states
  • Sold at Authorized Medical Distributors, Direct Sales
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD Kiestra Isolate Suspension Cuvettes Recalled for Barcode Errors

  • Sold in 7 states
  • Sold at Hospital supply distributors, Laboratory equipment suppliers
  • 29,760 units affected
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox Laboratories Ltd.: Liquid Protein Calibrators Recalled for Ingredient Realignment

  • Sold in 7 states
  • Sold at Authorized medical distributors
Recalled
Added
Microbiologics
Medium RiskFDA Device

Microbiologics Quality Control Kits Recalled for Bacterial Contamination

  • Sold in Utah, Ohio
  • Sold at Microbiologics Inc
  • Staphylococcus epidermidis contamination
Recalled
Added
Beckman Coulter
High RiskFDA Device

Beckman Coulter DxI 9000 Immunoassay Analyzer Recalled for Motor Misalignment

  • Distributed nationwide
  • Sold at Direct from manufacturer, Authorized medical device distributors
Recalled
Added
Remel
Medium RiskFDA Device

Remel, Inc: Todd Hewitt Broth w/CNA (LIM) Recalled for Failure to Detect Target Bacteria

  • Distributed nationwide
  • Sold at Laboratory distributors, Direct sales from Remel, Inc.
Recalled
Added
Medium RiskFDA Device

Siemens IMMULITE 2000 Intact PTH Assays Recalled for Falsely Low Results

  • Sold in 13 states
  • Sold at Hospitals, Medical Laboratories +1 more
Recalled
Added
Accriva Diagnostics
Medium RiskFDA Device

Hemochron Test Cuvettes Recalled for Potential Sharp Foreign Objects

  • Sold in 24 states
  • Sold at Medical distributors, Direct laboratory sales
  • Sharp foreign object contamination
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Access Intact PTH Assay Recalled for False Test Results

  • Distributed nationwide
  • Sold at Beckman Coulter Inc.
Recalled
Added
DICOM Grid
Medium RiskFDA Device

Intelerad InteleShare Software Recalled for Inaccurate Measurement Tool Bug

  • Sold in 45 states
  • Sold at Authorized Distributors, Direct Sales
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

Becton Dickinson & Co.: BD Phoenix Microbiology Panels Recalled for Drug Contamination and Testing Errors

  • Distributed nationwide
  • Sold at Hospital laboratories, Diagnostic centers +1 more
  • Esculin, Drug cross contamination contamination
Recalled
Added
B-K Medical A/S
Medium RiskFDA Device

B-K Medical A/S: bkActiv Ultrasound Systems Recalled for Potential Measurement Errors

  • Sold in 26 states
  • Sold at Direct medical sales, Authorized distributors
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Respiratory Panel 2.1 Recalled for False Negative Risk

  • Sold in Idaho, Oregon, Arizona
  • Sold at Medical distributors, Laboratory suppliers
Recalled
Added
Medium RiskFDA Device

PHASE SCIENTIFIC INTERNATIONAL LIMITED: INDICAID COVID-19 Rapid Antigen At-Home Test Recalled for Incorrect Expiration

  • Sold in 38 states
  • Sold at US Nationwide distribution
Recalled
Added
CHANGE HEALTHCARE CANADA
Medium RiskFDA Device

CHANGE HEALTHCARE CANADA COMPANY: Radiology Solutions Software Recalled for Failing to Update Medical Records

  • Distributed nationwide
  • Sold at Change Healthcare Canada Company
Recalled
Added
Roche Diagnostics Operations
Medium RiskFDA Device

Roche Diagnostics Operations, Inc.: Creatine Kinase (CK) Assay Recalled for Erroneous Results and Misdiagnosis

  • Distributed nationwide
  • Sold at Roche Diagnostics authorized distributors
Recalled
Added
Horiba Instruments
High RiskFDA Device

Horiba Instruments Incorporated: Modular Fluorolog-QM Fluorescence Instruments Recalled for Laser Safety Defect

  • Distributed nationwide
  • Sold at Horiba Instruments Incorporated
Recalled
Added
Beckman Coulter
High RiskFDA Device

Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Potential False Test Results

  • Sold in Indiana
  • Sold at Beckman Coulter, Inc.
Recalled
Added
Medium RiskFDA Device

Philips Zenition 50 and 70 Mobile C-Arm Systems Recalled for Fuse Failure

  • Distributed nationwide
  • Sold at Philips Medical Systems, Authorized Medical Device Distributors
Recalled
Added
Xcision Medical Systems
Medium RiskFDA Device

Xcision Medical Systems, LLC: GammaPod Treatment Planning System Recalled for Incorrect Treatment Maps

  • Sold in Maryland, Pennsylvania, Texas
  • Sold at Specialized Medical Distributors
Recalled
Added
Roche Diagnostics Operations
Medium RiskFDA Device

Roche Elecsys Anti-TSHR Immunoassay Recalled for Inconsistent Results

  • Sold in 21 states
  • Sold at Laboratory suppliers, Direct from manufacturer
Recalled
Added
Medium RiskFDA Device

Siemens Atellica CH Reaction Ring Cuvette Segments Recalled for Lab Error Risk

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Clinical Laboratories
Recalled
Added