Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(226)Monitoring Devices(265)Diagnostic Equipment(820)Home Healthcare(225)Contact Lenses & Vision(17)Surgical Equipment(893)

820 recalls

per page
Altruan
Medium RiskFDA Device

Altruan GmbH Strep A At-Home Tests Recalled for Lack of FDA Clearance

  • Distributed nationwide
Recalled
Added
Physio-Control
High RiskFDA Device

Physio-Control Infant/Child Defibrillator Electrodes Recalled for Delamination

  • Sold in 48 states
  • Sold at Authorized Medical Distributors, Direct Sales
  • 16,499 units affected
Recalled
Added
Instrumentation Laboratory
Medium RiskFDA Device

GEM Premier 5000 PAK Cartridges Recalled for Testing Delay Risk

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Instrumentation Laboratory Direct Sales
Recalled
Added
Beckman Coulter Mishima K.K.
Medium RiskFDA Device

Beckman Coulter Clinical Chemistry Analyzers Recalled for Software DB Error

  • Sold in 36 states
  • Sold at Beckman Coulter authorized distributors
Recalled
Added
Biocartis Nv
Medium RiskFDA Device

Biocartis Idylla Instruments Recalled for False-Positive Test Results

  • Sold in 5 states
  • Sold at Clinical laboratories, Medical distributors
Recalled
Added
Sysmex America
Medium RiskFDA Device

Sysmex PS-10 Sample Preparation System Recalled for False Lab Results

  • Distributed nationwide
  • Sold at Sysmex America, Inc.
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, INc.: VITROS ECO2 Slides Recalled for Potential Incorrect Carbon Dioxide Results

  • Distributed nationwide
  • Sold at Clinical laboratories, Hospitals +1 more
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: DCA Systems HbA1c Reagent Kits Recalled for Erroneous Test Results

  • Distributed nationwide
  • 74,211 units affected
Recalled
Added
Biocare Medical
Medium RiskFDA Device

Biocare Medical DAB Chromogen Buffer Kits Recalled for Staining Failures

  • Sold in 19 states
  • Sold at Direct distribution, Medical distributors
Recalled
Added
Medium RiskFDA Device

Philips IntelliSpace Cardiovascular Software Recalled for Data Export Failure

  • Sold in 22 states
  • Sold at Government distribution, Medical facilities
Recalled
Added
Medium RiskFDA Device

Atellica CH Diluent Recalled for Sodium Hypochlorite Contamination

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Inc.
  • Sodium hypochlorite (NaOCl) contamination
Recalled
Added
Agilent Technologies
Medium RiskFDA Device

GenetiSure Dx Labeling Kits Recalled for Potential DNA Analysis Errors

  • Sold in Massachusetts
  • Sold at Agilent Technologies, Inc.
Recalled
Added
Medium RiskFDA Device

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Systems Recalled for Potential X-ray Loss and Procedure Stops

  • Distributed nationwide
  • Sold at Philips Medical Systems, Direct medical device distributors
Recalled
Added
Micro-X
Medium RiskFDA Device

Micro-X Rover Mobile X-ray Systems Recalled for Radiation Delivery Error

  • Sold in New Jersey, California, Puerto Rico
  • Sold at Medical device distributors, Hospitals +1 more
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter DxH Diluents Recalled for Elevated Platelet Counts

  • Sold in 46 states
  • Sold at Clinical laboratories, Medical distributors
  • 76,098 units affected
Recalled
Added
Randox Laboratories
Low RiskFDA Device

Randox Laboratories Ltd.: Serology ToRCH IgM Positive Control Recalled for Reduced Reactivity

  • Sold in New York, West Virginia
Recalled
Added
Remel
Medium RiskFDA Device

Remel CAMHB and Brucella Broth Recalled for Media Contamination

  • Sold in 24 states
  • Sold at Laboratory distributors
  • Unspecified contamination contamination
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Synchron Systems Direct LDL Cholesterol Reagent Recalled for False High Results

  • Sold in 31 states
  • Sold at Clinical laboratories, Healthcare facilities +1 more
Recalled
Added
Hologic
Medium RiskFDA Device

Hologic Inc: Digital Mammography Software Recalled for Blurry Images and Misdiagnosis Risk

  • Distributed nationwide
  • Sold at Hologic Inc
Recalled
Added
Geneoscopy
Medium RiskFDA Device

ColoSense Test Kits Recalled for Diagnostic Plate Failures

  • Sold in Missouri
  • Sold at Laboratory facilities, Direct distribution
Recalled
Added
Immunotech A.S.
Medium RiskFDA Device

Immunotech Estrone RIA Kits Recalled for False Test Results

  • Sold in North Carolina
  • Sold at Healthcare professionals, Medical distributors
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

Becton Dickinson & Co.: BD BACTEC Plus Aerobic/F Culture Vials Recalled for Duplicate Barcodes

  • Distributed nationwide
  • Sold at Medical distributors, Healthcare facilities
  • 781,600 units affected
Recalled
Added
Accure Acne
Medium RiskFDA Device

Accure Acne, Inc: Accure Laser Systems Recalled Due to Misalignment and Blistering Risk

  • Sold in 10 states
  • Sold at Direct distribution to medical facilities
  • Possible risk of blistering; specific incident counts not provided in data.
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Access Cortisol Assays Recalled for Calibration Failure Risks

  • Distributed nationwide
  • Sold at Worldwide distribution, Authorized laboratory distributors
Recalled
Added