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Diagnostic Equipment

AllImplants & Prosthetics(228)Monitoring Devices(259)Diagnostic Equipment(818)Home Healthcare(219)Contact Lenses & Vision(17)Surgical Equipment(898)

818 recalls

per page
Philips North America
Medium RiskFDA Device

Philips North America Llc: Spectral CT 7500 Systems Recalled for Multiple Software Issues

  • Distributed nationwide
  • Sold at Philips Healthcare, Authorized Medical Device Distributors
Recalled
Added
Medium RiskFDA Device

Beckman Coulter Biomedical Division: Transferrin Reagent Recalled Due to Potential for Erroneous Lab Results

  • Sold in 42 states
  • Sold at Beckman Coulter, Medical laboratories +1 more
  • 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases reported.
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Software Errors and Testing Delays

  • Sold in 11 states
  • Sold at Beckman Coulter, Direct laboratory sales
Recalled
Added
Medium RiskFDA Device

Siemens Medical Solutions USA, Inc: ARTIS icono Ceiling System Recalled for Potential Collision Sensor Malfunction

  • Sold in 11 states
  • Sold at Siemens Medical Solutions USA, Inc
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Access Testosterone Assay Recalled for Inaccurate Results

  • Sold in Florida
  • Sold at Authorized distributors
  • Testosterone reagent (cross-contamination) contamination
Recalled
Added
Microgenics
Medium RiskFDA Device

Thermo Scientific MAS Omni CARDIO Controls Recalled for Inconsistent Results

  • Sold in 12 states
  • Sold at Authorized distributors, Medical supply retailers
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: Incisive CT X-Ray Systems Recalled for Tabletop Collision Risk

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Direct Sales
Recalled
Added
Medium RiskFDA Device

Leica HistoCore PELORIS 3 Tissue Processors Recalled for Tubing Leakage

  • Sold in 14 states
  • Sold at authorized medical distributors
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox Laboratories Ltd.: Total Bilirubin Reagents Recalled Due to Risk of Elevated Patient Results

  • Sold in 5 states
  • Sold at Medical laboratories, Healthcare facilities
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD BBL Sensi Disc Ampicillin Recalled for Potency Loss

  • Sold in 8 states
  • Sold at Becton Dickinson & Co., Medical distributors
  • 13,190 units affected
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: Proboscis/Piston Assemblies Recalled for Risk of Incorrect Lab Results

  • Distributed nationwide
  • Sold at QuidelOrtho, Ortho Clinical Diagnostics
Recalled
Added
Baxter Healthcare
Critical RiskFDA Device

Baxter Healthcare Corporation: Exactamix Pro 1200 and 2400 Recalled for Software-Related Over-Delivery Risk

  • Sold in 22 states
  • Sold at Authorized Medical Distributors
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD Synapsys Software Recalled for Incorrect Antibiotic Breakpoint Displays

  • Distributed nationwide
  • Sold at Becton Dickinson & Co., Clinical laboratories
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox Laboratories Ltd.: Calibration Serum and Multi-Sera Recalled for Incorrect Target Values

  • Distributed nationwide
  • Sold at Authorized medical distributors
Recalled
Added
NOXBOX
Medium RiskFDA Device

NOxBOXi Nitric Oxide Delivery System Recalled for Sample Pump Failure

  • Sold in Tennessee
  • Sold at Authorized medical device distributors
Recalled
Added
Medium RiskFDA Device

Shimadzu CH-200 and CH-200M X-Ray Tube Supports Recalled for Shaft Breakage

  • Distributed nationwide
  • Sold at Medical equipment distributors, Authorized hospital supply networks
Recalled
Added
Ambu
Medium RiskFDA Device

Ambu aScope 5 Broncho HD Sampler Sets Recalled for Incorrect Size Labeling

  • Sold in 13 states
  • Sold at Medical distributors
Recalled
Added
Medium RiskFDA Device

Shimadzu Trinias unity Angiography Systems Recalled for Unintended Movement

  • Sold in 6 states
  • Sold at Authorized medical device distributors, Hospitals
Recalled
Added
Randox Laboratories
Medium RiskFDA Device

Randox Laboratories Ltd.: Cystatin C Reagent Recalled for Lacking Required FDA Clearance

  • Sold in 4 states
  • Sold at Authorized distributors
Recalled
Added
Medium RiskFDA Device

Shimadzu Autosamplers Recalled for Short Circuit and Testing Delay Risk

  • Sold in 25 states
  • Sold at Authorized distributors, Shimadzu Corporation direct sales
Recalled
Added
Cepheid
Medium RiskFDA Device

Cepheid: Xpert Xpress Strep A Kits Recalled for Faulty Sample Pipettes

  • Distributed nationwide
  • Sold at Rx Only, Worldwide distributors
  • 91,371 units affected
Recalled
Added
Fujifilm Irvine Scientific
Medium RiskFDA Device

Fujifilm Irvine Scientific, Inc.: Sperm Separation Kits Recalled Due to Component Mismatch and Expired Parts

  • Sold in 21 states
  • Sold at Specialty medical distributors, Fertility clinics
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

DxI 9000 Access Immunoassay Analyzer Recalled for Calibration Issues

  • Sold in 24 states
  • Sold at Beckman Coulter, Inc., Direct laboratory sales
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Incisive CT Systems Recalled Due to Risk of Flying Components

  • Distributed nationwide
  • Sold at Direct sales, Medical equipment distributors
  • Metal fragments contamination
Recalled
Added