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

UniCel DxH Cellular Analysis Systems Recalled for Incorrect Hemoglobin Results

  • Sold in 37 states
  • Sold at Medical device distributors, Direct laboratory sales
Recalled
Added
Medium RiskFDA Device

DVOT Rapid Test Kits Recalled for Lack of FDA Authorization

  • Distributed nationwide
  • Sold at International distribution
  • 320,000 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Zenition and Veradius Medical Systems Recalled for Radiation Risk

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Medline Industries
Critical RiskFDA Device

Medline Reprocessed Catheters Recalled for Potential Residual Material

  • Distributed nationwide
  • Sold at Hospital supply channels, Medical device distributors
  • residual material contamination
Recalled
Added
Natus Neurology
Medium RiskFDA Device

Natus Neurology Inc: Tensive Conductive Adhesive Gel Recalled for Irritation and Quality Issues

  • Distributed nationwide
  • Sold at Natus Neurology Inc
  • 1 report of patient irritation after a procedure
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, INc.: VITROS Lipase Slides Recalled for Incorrect Results and Diagnosis Risk

  • Sold in 12 states
  • Sold at Clinical laboratories, Healthcare facilities
Recalled
Added
Philips North America
Critical RiskFDA Device

Philips North America: BrightView Gamma Camera Systems Recalled for Falling Detector Risk

  • Distributed nationwide
  • Sold at Authorized medical equipment distributors
  • Potential for abrasion, contusion, laceration, and/or fracture; no specific injury counts provided.
Recalled
Added
Canon Medical System, USA
Medium RiskFDA Device

Canon Digital Radiography Systems Recalled for Software Error

  • Distributed nationwide
  • Sold at Hospitals, Diagnostic centers
Recalled
Added
Medium RiskFDA Device

Mckesson Medical-Surgical Inc. Corporate Office: Medical Diagnostic Control Kits Recalled Due to Temperature Storage Failure

  • Sold in Arizona, Pennsylvania, Texas
  • Sold at McKesson Medical-Surgical Inc.
Recalled
Added
Medium RiskFDA Device

epoc BGEM BUN Test Cards Recalled for Inaccurate Sodium Readings

  • Distributed nationwide
  • Sold at Medical distributors, Hospitals +1 more
  • 37,554 units affected
Recalled
Added
Agfa N.V.
Medium RiskFDA Device

Agfa N.V.: DR 800 X-ray System Recalled Due to Potential Table Lever Chain Failure

  • Sold in 16 states
  • Sold at Authorized medical device distributors, Agfa direct sales
Recalled
Added
Beckman Coulter Mishima K.K.
Medium RiskFDA Device

Beckman Coulter Mishima K.K.: DxC 500 AU Clinical Chemistry Analyzer Recalled for Software Issue

  • Sold in 13 states
  • Sold at Beckman Coulter, Direct distribution to clinical laboratories
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Atellica CH Reagents Recalled Due to Reagent Carryover and Measurement Bias

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Inc., Medical laboratory distributors
  • 94,949 units affected
Recalled
Added
Defibtech
High RiskFDA Device

Defibtech Defibrillation Pads Recalled Due to Labeling and Expiration Risks

  • Sold at Authorized distributors
  • 22,294 units affected
Recalled
Added
Cellavision AB
Medium RiskFDA Device

Cellavision DI-60 Analyzers Recalled for Barcode Reading Errors

  • Sold in 51 states
  • Sold at Medical device distributors, Laboratory equipment suppliers
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: QMS Tacrolimus Calibrators Recalled for Degradation and Improper Storage

  • Sold in 6 states
  • Sold at authorized distributors
Recalled
Added
NRT X-RAY A/S
Medium RiskFDA Device

NRT X-RAY A/S: Intelli-C X-ray Systems Recalled for Risk of Uncontrolled C-arm Motion

  • Sold in 16 states
  • Sold at Direct sales to healthcare facilities, Authorized medical equipment distributors
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Access hsTnI Reagent Recalled for Falsely Elevated Patient Results

  • Distributed nationwide
  • Sold at medical laboratories, hospitals
  • High troponin antigen carryover contamination
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Pneumonia Panels Recalled for Manufacturing Defect

  • Sold in West Virginia, Indiana, Alabama
  • Sold at Authorized medical distributors
Recalled
Added
GE Vingmed Ultrasound As
Medium RiskFDA Device

GE Vingmed Ultrasound As: Vivid Ultrasound Systems Recalled for Potential Display of Incorrect Patient Data

  • Sold in 5 states
  • Sold at Authorized distributors, Medical facilities
Recalled
Added
PTW-FREIBURG
Medium RiskFDA Device

PTW-FREIBURG: VERIQA Software Recalled for Incorrect Radiation Dose Calculations

  • Sold in Georgia
  • Sold at Specialty medical distributors
Recalled
Added
Medium RiskFDA Device

Siemens LUMINOS Q.namix X-Ray Systems Recalled for Image Processing Errors

  • Sold in 8 states
  • Sold at Authorized Medical Device Distributors, Direct Sales
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: FilmArray Pneumonia Panels Recalled for Potential False Positive Results

  • Sold in 46 states
  • Sold at BioFire Diagnostics, Healthcare facilities +1 more
  • 488,370 units affected
Recalled
Added
UIH Technologies
Medium RiskFDA Device

United Imaging CT and PET/CT Systems Recalled for Mechanical Interference

  • Distributed nationwide
  • Sold at Authorized Medical Equipment Distributors, Healthcare Facilities +1 more
Recalled
Added