Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(225)Monitoring Devices(272)Diagnostic Equipment(819)Home Healthcare(232)Contact Lenses & Vision(17)Surgical Equipment(890)

819 recalls

per page
Medline Industries
Medium RiskFDA Device

Medline and Centurion Medical Kits Recalled for Non-Sterile Alcohol Pads

  • Distributed nationwide
  • Sold at Hospital supply distributors, Medical supply channels
  • Paenibacillus phoenicis contamination
Recalled
Added
Immuno-Mycologics
Medium RiskFDA Device

Immy Neutralization Buffer B Recalled for Potential Contamination

  • Sold in 11 states
  • Sold at Clinical laboratories, Medical distributors
  • Unknown contaminants contamination
Recalled
Added
Medium RiskFDA Device

Siemens epoc BGEM BUN Test Cards Recalled for Inaccurate Results

  • Distributed nationwide
  • Sold at Authorized distributors
  • 71,725 units affected
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD GasPak EZ CO2 and Campy Pouch Systems Recalled for Low Gas Levels

  • Distributed nationwide
  • Sold at Wholesalers, Direct distribution
  • 27,960 units affected
Recalled
Added
Abbott Point Of Care
High RiskFDA Device

i-STAT Cartridges Recalled for Potential False Blood Gas Results

  • Distributed nationwide
  • Sold at Authorized medical distributors
  • 440,700 units affected
Recalled
Added
Low RiskFDA Device

Heraeus Medical PALAMIX Mixing Devices Recalled for Reduced Shelf Life

  • Distributed nationwide
  • Sold at dental supply distributors, specialty dental retailers
  • 52,896 units affected
Recalled
Added
Biomerieux
Medium RiskFDA Device

VITEK 2 Gram-negative Susceptibility Cards Recalled for Testing Failures

  • Distributed nationwide
  • Sold at Direct distribution to laboratories and hospitals
  • 2,668,954 units affected
Updated
Recalled
Medium RiskFDA Device

Dimension Creatinine Flex Reagent Cartridges Recalled for Inaccurate Results

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Laboratory supply distributors
  • 18,080 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips MRE Scanning Systems Recalled for Accuracy Errors

  • Distributed nationwide
  • Sold at Authorized Philips medical equipment distributors, Direct sales to hospitals and clinics
Recalled
Added
Milestone S.R.L.
Medium RiskFDA Device

Milestone VACUUM BAG SU LARGE Specimen Containers Recalled for Reagent Leakage

  • Distributed nationwide
  • Sold at authorized medical distributors
  • reagents contamination
Recalled
Added
Hologic
Medium RiskFDA Device

Genius Review Station Recalled Due to Misconfigured Display Settings

  • Distributed nationwide
  • Sold at Hologic, Inc., Authorized medical device distributors
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

Hamilton AutoLys STAR Software Recalled for Spontaneous Closures

  • Sold in North Carolina, Massachusetts
  • Sold at Foundation Medicine, Inc., Research Triangle Park Laboratory
Recalled
Added
Remel Europe
Medium RiskFDA Device

Oxoid Agglutinating Sera Recalled for Potential Salmonella Misidentification

  • Sold in 15 states
  • Sold at Authorized laboratory distributors
Recalled
Added
Micro-X
Medium RiskFDA Device

Rover Mobile X-ray Systems Recalled Due to Generator Malfunction

  • Sold in 4 states
  • Sold at Micro-X Ltd.
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

FoundationOne CDx Sequencing Agents Recalled for False-Positive Test Results

  • Sold in Massachusetts, North Carolina
  • Sold at Foundation Medicine, Inc.
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Access Total T4 Calibrator Recalled for Inaccurate Patient Test Results

  • Distributed nationwide
  • Sold at Medical laboratories, Hospitals
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD BACTEC MGIT 960 PZA Kits Recalled for False Resistance Results

  • Distributed nationwide
  • Sold at Laboratory supply distributors, Medical wholesalers
  • 12,256 units affected
Updated
Recalled
Magellan Diagnostics
Medium RiskFDA Device

Magellan Diagnostics LeadCare Blood Lead Test Kits Recalled for False Results

  • Distributed nationwide
  • Sold at Authorized medical device distributors
  • 198,313 units affected
Recalled
Added
Critical RiskFDA Device

Siemens MAGNETOM and Biograph MRI Systems Recalled for Helium Leak Risk

  • Distributed nationwide
  • Sold at authorized medical distributors, specialty retailers
  • Helium gas contamination
Updated
Recalled
Medium RiskFDA Device

ARTIS Pheno Systems Recalled for Unintentional Radiation Exposure Risk

  • Distributed nationwide
  • Sold at Siemens Medical Solutions USA, Inc.
Recalled
Added
Gentuity
Medium RiskFDA Device

Gentuity HF-OCT Imaging Systems Recalled for Measurement Errors

  • Sold in 11 states
  • Sold at Authorized Medical Distributors
Recalled
Added
PHILIPS MEDICAL SYSTEMS
Medium RiskFDA Device

Philips Spectral CT on Rails Recalled for Software Defects

  • Sold in Minnesota
  • Sold at Philips Medical Systems, Direct distribution
Recalled
Added
B Braun Medical
Critical RiskFDA Device

B. Braun Hemodialysis Bloodlines Recalled for Air Bubble Risk

  • Distributed nationwide
  • Sold at Medical distributors, Dialysis centers
  • 7,324,458 units affected
Recalled
Added
Remel
Medium RiskFDA Device

Remel Yeastone Broth Recalled Due to Potential Incorrect Antifungal Results

  • Distributed nationwide
  • Sold at Direct distribution to laboratories and healthcare facilities
Recalled
Added