Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(229)Monitoring Devices(257)Diagnostic Equipment(818)Home Healthcare(218)Contact Lenses & Vision(17)Surgical Equipment(896)

818 recalls

per page
Philips North America
High RiskFDA Device

Philips MRI Systems Recalled Due to Smoke and Fire Risk

  • Sold in 8 states
  • Sold at Authorized Philips medical equipment distributors, Direct medical facility sales
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

BD Phoenix M50 and 100 Instruments Recalled for E. coli Misidentification

  • Distributed nationwide
  • Sold at Becton Dickinson & Co., Medical distributors
  • Escherichia coli contamination
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Breast and Interventional MRI Coils Recalled for Patient Injury Risk

  • Distributed nationwide
  • Sold at Authorized Philips medical device distributors, Direct hospital sales
  • Potential for patient harm mentioned; no specific injury counts provided.
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Welch Allyn Replacement Bladder Kits Recalled Due to Sizing Error

  • Sold in 4 states
  • Sold at Baxter Healthcare Corporation, Authorized medical distributors
Recalled
Added
Abbott Point Of Care
Medium RiskFDA Device

Abbott i-STAT CG4+ Cartridges Recalled for Lack of Premarket Clearance

  • Distributed nationwide
  • Sold at Medical distributors, Authorized distributors
  • 9,067,050 units affected
Recalled
Added
Abbott Laboratories
Medium RiskFDA Device

Abbott Laboratories: Alinity ci-series System Software Recalled for Performance and Report Errors

  • Sold in 46 states
  • Sold at Authorized medical distributors
Recalled
Added
Micro-X
Medium RiskFDA Device

Micro-X Rover Mobile X-ray System Recalled for Diagnostic Exposure Issue

  • Sold in New Jersey, Puerto Rico, California
  • Sold at Authorized medical device distributors, Micro-X Ltd.
Recalled
Added
GE HEALTHCARE AUSTRIA GMBH
Medium RiskFDA Device

GE HEALTHCARE AUSTRIA GMBH & CO: Voluson IC9-RS Ultrasound Probes Recalled Due to Misdiagnosis Risk

  • Distributed nationwide
  • Sold at Authorized GE Healthcare medical equipment distributors
  • 12,004 units affected
Recalled
Added
Wondfo USA
Medium RiskFDA Device

Wondfo USA Co Ltd: Preview Strep A Test Kits Recalled for Unauthorized At-Home Use

  • Distributed nationwide
  • Sold at Wondfo USA Co Ltd, Clarity Diagnostics LLC +6 more
  • 1,586,255 units affected
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Atellica CH Reagents Recalled Due to Potential for Incorrect Magnesium Results

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Medical supply distributors
  • 38,630 units affected
Recalled
Added
Medium RiskFDA Device

Medline Medical Specimen and Urine Collection Kits Recalled for Sterility Issue

  • Sold in 13 states
  • Sold at Medline Industries, Medical distributors
  • 626,305 units affected
Recalled
Added
Medium RiskFDA Device

Philips Allura Xper Systems Recalled for Motorized Movement Failure

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

Carestream Health, Inc.: DRX Revolution Mobile X-Ray Systems Recalled for Electrical Component Failure

  • Distributed nationwide
  • Sold at Hospitals, Medical centers +1 more
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS Anti-HBs Reagent Packs and Calibrators Recalled for False Results

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

Angiodynamics, Inc.: Soft-Vu Kumpe Catheters Recalled for Mislabeled Catheter Length

  • Distributed nationwide
  • Sold at Medical distributors, Direct hospital sales
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Diagnostics, LLC: BioFire Diagnostic Panels Recalled for Risk of False Negative Results

  • Sold in 16 states
  • Sold at Medical laboratories, Healthcare facilities
Recalled
Added
RAYSEARCH LABORATORIES AB
Medium RiskFDA Device

RayStation Radiation Therapy Planning Software Recalled for Data Unique ID Issue

  • Sold in 18 states
  • Sold at Authorized distributors, Direct medical software sales
Recalled
Added
Medium RiskFDA Device

Philips Allura Xper Imaging Systems Recalled for Short-Circuit Risk

  • Distributed nationwide
  • Sold at Hospitals, Medical facilities +1 more
  • Coolant liquid contamination
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Total Bilirubin Flex Reagent Cartridges Recalled for Underfilled Wells

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Inc.
Recalled
Added
Beckman Coulter Mishima K.K.
Medium RiskFDA Device

Beckman Coulter Analyzer Sample Probes Recalled for False Low Results

  • Distributed nationwide
  • Sold at Beckman Coulter Mishima K.K., Authorized Medical Device Distributors
  • 16,342 units affected
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter Estrone RIA Kits Recalled for Falsely High Assay Results

  • Sold in North Carolina
  • Sold at Beckman Coulter Authorized Distributors
Recalled
Added
Hologic
Medium RiskFDA Device

Panther Fusion GBS Assay Cartridges Recalled for Potential Weak Pouch Seal

  • Sold in 20 states
  • Sold at Clinical laboratories, Healthcare facilities
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic CareLink SmartSync Software Recalled for Erroneous Reset Messages

  • Distributed nationwide
  • Sold at Medtronic Direct Sales, Authorized Medical Distributors
  • 39 reports of erroneous reset messages and 2 instances of unnecessary device explant through April 30, 2025.
Recalled
Added
FUJIFILM Healthcare Americas
Medium RiskFDA Device

FUJIFILM Healthcare Americas Corporation: Synapse PACS Software Recalled for Incorrect Medical Measurements

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