Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(230)Monitoring Devices(252)Diagnostic Equipment(818)Home Healthcare(215)Contact Lenses & Vision(17)Surgical Equipment(896)

818 recalls

per page
Ortho-Clinical Diagnostics
Medium RiskFDA Device

VITROS Chemistry CRP Slides Recalled for Incorrect Test Results

  • Sold in 10 states
  • Sold at Clinical laboratories, Hospitals
Recalled
Added
Medium RiskFDA Device

Olympus Gastrointestinal Videoscope Recalled for Disinfection Risks

  • Sold in 44 states
  • Sold at Authorized medical distributors
Recalled
Added
Medium RiskFDA Device

GE HealthCare MUSE 5 Cardiovascular Systems Recalled for Data Security Risk

  • Distributed nationwide
  • Sold at GE HealthCare authorized distributors, Medical equipment suppliers
Recalled
Added
High RiskFDA Device

GE Nuclear Medicine Systems Recalled for Unintended Detector Motion

  • Distributed nationwide
  • Sold at Authorized distributors, GE Medical Systems
Recalled
Added
Bebig Isotopentechnik
Medium RiskFDA Device

Bebig Isotopentechnik Gmbh: SagiPlan 2.2 Brachytherapy System Recalled for Inaccurate Measurements

  • Sold in Maryland
  • Sold at Specialized medical software distributors
Recalled
Added
Medium RiskFDA Device

Becton, Dickinson and Company, BD Biosciences: BD Multitest Reagents Recalled Due to Compromised Raw Material

  • Sold in 34 states
  • Sold at Direct distribution to laboratories and healthcare facilities
  • 10,027 units affected
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Phosphorus Reagents Recalled for Calibration Failure

  • Sold in 15 states
  • Sold at Hospitals, Diagnostic Laboratories +1 more
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox CRP Immunoturbidimetric Reagents Recalled for Inaccurate Test Results

  • Sold in Pennsylvania, Ohio, West Virginia
  • Sold at Randox Laboratories
Recalled
Added
DIGIMED
Medium RiskFDA Device

DIOX-602 Portable X-ray Systems Recalled for Insufficient SSD Distance

  • Distributed nationwide
  • Sold at Medical and dental equipment distributors
Recalled
Added
Cepheid
Medium RiskFDA Device

Cepheid Xpert SA Nasal Complete Kits Recalled for False Negative Risk

  • Sold in 44 states
  • Sold at Diagnostic Laboratories, Medical Wholesalers +1 more
Recalled
Added
Magellan Diagnostics
Medium RiskFDA Device

LeadCare II Blood Lead Test Kits Recalled for Mislabeled Calibration Buttons

  • Distributed nationwide
  • Sold at Nationwide distribution
Recalled
Added
Sysmex America
Medium RiskFDA Device

Sysmex TS-10/TS-10H Tube Sorters Recalled for Unexpected Lift Movement

  • Distributed nationwide
  • Sold at Authorized Sysmex distributors
Recalled
Added
Inpeco S.A.
Medium RiskFDA Device

FlexLab Aliquoter Module Recalled for Risk of Mismatched Sample Labels

  • Sold in Michigan
  • Sold at Authorized distributors, Direct laboratory sales
Recalled
Added
FUJIFILM Healthcare Americas
Medium RiskFDA Device

Fujifilm Synapse PACS Software Recalled for Incorrect Patient Age Display

  • Sold in 30 states
  • Sold at Direct Sales, FUJIFILM Healthcare Americas Corporation
Recalled
Added
Diasorin
Medium RiskFDA Device

Diasorin Inc.: LIAISON HSV-2 IgG Assay Recalled for False Positive Results

  • Distributed nationwide
  • Sold at Laboratories, Hospitals +1 more
  • 31,992 units affected
Recalled
Added
Illumina
Medium RiskFDA Device

NextSeq 550Dx Reagent Kits Recalled for Gasket Defect and Leakage Risk

  • Sold in 17 states
  • Sold at Illumina, Inc., Laboratory supply distributors
  • 11,916 units affected
Recalled
Added
Ortho-Clinical Diagnostics
High RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS XT ALB-TP Slides Recalled for Debris Causing Incorrect Lab Results

  • Distributed nationwide
  • Sold at Direct to clinical laboratories, Medical device distributors
  • dust, debris contamination
Recalled
Added
Medium RiskFDA Device

Olympus TJF-Q190V Duodenoscopes Recalled Due to Infection Risk

  • Distributed nationwide
  • Sold at Authorized medical distributors, Olympus Corporation of the Americas
  • Continued reports of positive cultures and infections.
Recalled
Added
Silkprousa
Medium RiskFDA Device

Silkprousa LLC: Pink Luminous Breast Device Recalled for Lack of FDA Approval

  • Sold in Washington, Rhode Island
  • Sold at Silkprousa LLC
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD COR System Software Recalled for Potential False Negative Results

  • Sold in Florida, Texas, Michigan
  • Sold at Authorized distributors
Recalled
Added
Schiller, Ag
Medium RiskFDA Device

Schiller, Ag: CARDIOVIT AT-180 Electrocardiographs Recalled for ECG Signal Artifacts

  • Sold in Florida
  • Sold at authorized distributors
Recalled
Added
DRG International
Low RiskFDA Device

DRG T4 Total ELISA Test Kits Recalled for Incorrect Expiration Dates

  • Sold in California, Massachusetts, Pennsylvania
  • Sold at Authorized distributors, Direct sales
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter, Inc.: Dxl 9000 Access Immunoassay Analyzers Recalled for Corroding USB Cables

  • Sold in 6 states
  • Sold at Beckman Coulter, Inc. authorized distributors, Direct healthcare facility sales
Recalled
Added
Medium RiskFDA Device

BD FACSLyric Flow Cytometers Recalled for Power Supply Failure and Fumes

  • Sold in 27 states
  • Sold at BD Bio Sciences, Authorized Medical Distributors
Recalled
Added