Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(226)Monitoring Devices(263)Diagnostic Equipment(818)Home Healthcare(223)Contact Lenses & Vision(17)Surgical Equipment(895)

818 recalls

per page
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: BioFire BCID2 Panels Recalled for False Positive Candida tropicalis Results

  • Sold in 51 states
  • Sold at Hospital laboratories, Medical diagnostic facilities
  • non-viable Candida tropicalis DNA fragments contamination
Recalled
Added
Medium RiskFDA Device

Philips Vue PACS Diagnostic Viewer Recalled for Software-Induced Misdiagnosis Risk

  • Distributed nationwide
  • Sold at Hospitals, Medical Institutions
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recalled for Software Defect

  • Sold in 25 states
  • Sold at Beckman Coulter Inc., Professional medical laboratories
Recalled
Added
PIE Medical Imaging B.V.
High RiskFDA Device

3mensio Vascular Fenestrated Software Recalled for Stent Placement Errors

  • Sold in 12 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

Becton Dickinson & Co.: BD Kiestra Urine Culture Application Recalled for Inaccurate Colony Counts

  • Sold in 17 states
  • Sold at Becton Dickinson & Co. authorized distribution
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

Becton Dickinson & Co.: SARS-CoV-2 Diagnostic Reagents Recalled for Potential False Negative Results

  • Distributed nationwide
  • Sold at Healthcare facilities, Diagnostic laboratories +1 more
Recalled
Added
Agilent Technologies
Medium RiskFDA Device

Agilent Technologies: Dako CoverStainer Recalled for Risk of Breaking Plexiglass Door

  • Sold in 12 states
  • Sold at Agilent Technologies
Recalled
Added
Medium RiskFDA Device

Philips Pinnacle 3 Therapy Planning Software Recalled for Calculation Errors

  • Distributed nationwide
  • Sold at hospitals, radiation therapy centers +1 more
Recalled
Added
Medium RiskFDA Device

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Trinias Digital Angiography System Recalled for Potential Display Failure

  • Sold in Ohio
  • Sold at Authorized medical distributors
Recalled
Added
Echopixel
Medium RiskFDA Device

Echopixel True 3D Viewer Recalled for Incorrect Image Orientation Risk

  • Sold in 11 states
  • Sold at Direct Sales, Medical Equipment Distributors
Recalled
Added
Medium RiskFDA Device

Philips Allura Xper X-Ray Systems Recalled for Missing Air Baffle

  • Sold in 29 states
  • Sold at Philips direct sales, Authorized medical device distributors
Recalled
Added
FUJIFILM Healthcare Americas
Medium RiskFDA Device

FUJIFILM Healthcare Americas Corporation: Noblus Ultrasound AC Adapters Recalled Due to Overheating and Smoke Risk

  • Distributed nationwide
  • Sold at FUJIFILM Healthcare Americas Corporation
Recalled
Added
Luminex
Medium RiskFDA Device

Luminex Corporation: Verigene Blood Culture Utility Trays Recalled for Potential Defects

  • Sold in 24 states
  • Sold at Authorized Luminex Distributors
Recalled
Added
Dynex Technologies
Medium RiskFDA Device

Dynex Agility Sample Tips Recalled for Mislabeling and Result Delays

  • Sold in 5 states
  • Sold at Laboratory distributors
Recalled
Added
Elekta
Medium RiskFDA Device

Elekta Medical Linear Accelerators Recalled for Electrical Grounding Issue

  • Distributed nationwide
Recalled
Added
GE Healthcare
Medium RiskFDA Device

GE Healthcare: Centricity Universal Viewer Zero Footprint Client Recalled for Hidden Reports

  • Distributed nationwide
  • Sold at GE Healthcare Authorized Sales
Recalled
Added
NIPRO Technical Services
Medium RiskFDA Device

NIPRO Conductivity Standard Solution Recalled for Incorrect Calibration Values

  • Sold in 27 states
  • Sold at Medical supply distributors
Recalled
Added
LEICA BIOSYSTEMS NUSSLOCH
High RiskFDA Device

LEICA BIOSYSTEMS NUSSLOCH GMBH: HistoCore Arcadia H Paraffin Embedding Stations Recalled for Fire Risk

  • Distributed nationwide
  • Sold at Government distribution, Authorized medical device distributors
  • Reports of internal fires and toxic smoke have occurred; specific injury counts not provided.
Recalled
Added
NeuroLogica
Medium RiskFDA Device

NeuroLogica Corporation: Digital Mobile X-Ray Systems Recalled for Potential Fall Risk

  • Sold in 18 states
  • Sold at NeuroLogica Corporation
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox Laboratories Ltd.: Liquid Assayed Chemistry Control Recalled for Incorrect Lab Test Values

  • Sold in 6 states
  • Sold at Clinical Laboratories, Medical Facilities
Recalled
Added
Edge Biologicals
Medium RiskFDA Device

Edge Biologicals Sterile Water Recalled for Mislabeled Packaging

  • Sold in Pennsylvania
  • Sold at laboratory distributors
Recalled
Added
Hologic
Medium RiskFDA Device

Hologic, Inc.: Aptima CMV Quant Assay Recalled for Potential Invalid Sample Results

  • Sold in 11 states
Recalled
Added
Critical RiskFDA Device

Siemens MAGNETOM Cima.X Upgrade Recalled for Helium Venting Defect

  • Sold in California
  • Sold at Siemens Medical Solutions USA, Inc.
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

FoundationOne Companion Diagnostic Recalled for Incorrect Test Results

  • Sold in Michigan
  • Sold at Foundation Medicine, Inc.
Recalled
Added