Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(225)Monitoring Devices(270)Diagnostic Equipment(819)Home Healthcare(231)Contact Lenses & Vision(17)Surgical Equipment(890)

819 recalls

per page
Linkbio
Medium RiskFDA Device

LinkBio CORE Workstation Recalled for Incorrect Planning Date Display

  • Sold in Alabama, Florida, Kansas
  • Sold at Specialty medical distributors
Recalled
Added
Instrumentation Laboratory
Medium RiskFDA Device

HemosIL Heparin Calibrators Recalled for Inaccurate Test Results

  • Distributed nationwide
  • Sold at Medical supply distributors, Direct hospital sales
  • 10,952 units affected
Updated
Recalled
Beckman Coulter
Medium RiskFDA Device

MicroScan Multidrug Resistant MIC 1 Panels Recalled for Manufacturing Issue

  • Sold at Direct distribution
Recalled
Added
Brahms
Medium RiskFDA Device

B.R.A.H.M.S PlGF Plus KRYPTOR Recalled for Inaccurate Test Results

  • Sold in 11 states
  • Sold at Healthcare facilities, Diagnostic laboratories
Recalled
Added
Medium RiskFDA Device

Siemens ARTIS X-Ray Systems Recalled for Incorrect Radiation Dose Displays

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

Centers For Disease Control and Prevention: Influenza A/H5 Subtyping Kit Recalled for Potential Inconclusive Results

  • Distributed nationwide
Recalled
Added
Philips Ultrasound
Medium RiskFDA Device

Philips Ultrasound, Inc.: 3D9-3v Ultrasound Transducers Recalled for Chassis Bonding Failure

  • Sold in 34 states
  • Sold at Authorized Philips medical device distributors, healthcare facilities
Recalled
Added
Philips Ultrasound
Medium RiskFDA Device

Philips Ultrasound, Inc.: EPIQ and Affiniti Ultrasound Systems Recalled for Delayed Imaging Software

  • Sold in 17 states
  • Sold at Authorized Philips medical equipment distributors
Recalled
Added
Molded Products
Medium RiskFDA Device

See Luer Cap Set Recalled for Detachment and Disconnection Risk

  • Sold in 5 states
  • Sold at hospital and medical supply channels
  • Confirmed complaint of sleeve detachment; no specific injury count provided.
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter DxI 9000 Analyzers Recalled for Software Error

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

VERIGENE Gram Negative Blood Culture Test Recalled for False Negative Results

  • Sold in 13 states
  • Sold at Clinical laboratories, Hospitals
Recalled
Added
Medium RiskFDA Device

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.: A1CNow+ HbA1c System Recalled for Potential Inaccurate Test Results

  • Distributed nationwide
  • Sold at authorized dealers, medical distributors
Recalled
Added
Landauer
Medium RiskFDA Device

Landauer: microSTARii Dosimetry Systems Recalled for Removal of Medical Use References

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Landauer
Recalled
Added
Accuray
Medium RiskFDA Device

Accuray Incorporated: Radixact System Upper Roller Bracket Recalled Due to Injury Risk

  • Sold in 11 states
  • Sold at Accuray Incorporated, Government distribution
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Philips Inclusive CT Systems Recalled for Software Display and Imaging Issues

  • Sold in 25 states
  • Sold at Authorized Philips medical equipment distributors, Direct sales to hospitals and clinics
Recalled
Added
Philips Ultrasound
Medium RiskFDA Device

Philips EPIQ Ultrasound Systems Recalled for Reboot and Transducer Damage

  • Distributed nationwide
  • Sold at Philips Ultrasound, LLC
Recalled
Added
Nomax
Low RiskFDA Drug

Nomax Inc: Dry Eye Test Ophthalmic Strips Recalled for Being Subpotent

  • Distributed nationwide
Recalled
Added
GE Healthcare
High RiskFDA Vet

GE Healthcare, LLC: LOGIQ P6 Ultrasound System Recalled for Potential Burn Injuries

  • Sold in 6 states
  • Sold at GE Healthcare, Medical distributors
  • Possibility of burn injuries to patients or operators
Recalled
Added
Charm Sciences
Medium RiskFDA Vet

Charm Sciences, Inc.: Charm SL-6 Beta Lactam Assay Kits Recalled for Risk of False Negatives

  • Distributed nationwide
  • Sold at Charm Sciences, Inc.
  • 125,000 units affected
Recalled
Added
bioMerieux
Medium RiskFDA Vet

bioMerieux VITEK 2 Automated Systems Recalled for Software Test Result Error

  • Sold in 9 states
  • Sold at Direct distribution
Recalled
Added
bioMerieux
Medium RiskFDA Vet

bioMerieux, Inc.: VITEK 2 AST Veterinary Test Kits Recalled for False Negative MRSA Results

  • Sold in 19 states
  • Sold at Authorized veterinary diagnostic distributors
  • Customer reports of non-detected MRSA cases.
Recalled
Added
Arkray Factory USA
Medium RiskFDA Vet

Arkray Factory USA, Inc.: Veterinary Glucose Test Strips Recalled for Incorrect Low Glucose Reports

  • Sold in 46 states
  • Sold at Veterinary clinics, Specialized veterinary distributors
Recalled
Added
Roche Diagnostics
Medium RiskFDA Vet

Roche Diagnostics Corp.: VetLyte ISE Fluid Pack Recalled for Defective Seam and Inaccurate Results

  • Distributed nationwide
  • Sold at IDEXX Laboratories, Inc.
  • 86,479 units affected
Recalled
Added
COVETRUS NORTH AMERICA
Medium RiskFDA Vet

COVETRUS NORTH AMERICA: scil SOLO Phenobarbital Test Kits Recalled for Falsely Low Results

  • Sold in 5 states
  • Sold at Covetrus North America
Recalled
Added