Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(230)Monitoring Devices(252)Diagnostic Equipment(818)Home Healthcare(215)Contact Lenses & Vision(17)Surgical Equipment(896)

2,689 recalls

per page
TRUE METRIX Blood Glucose System Recalled for Inadequate Error Guidance
Critical RiskFDA Device

TRUE METRIX Blood Glucose System Recalled for Inadequate Error Guidance

  • Distributed nationwide
  • Sold at Walgreens, CVS +28 more
  • 18,154,483 units affected
Recalled
Added
Beckman Coulter Mishima K.K.
Medium RiskFDA Device

Beckman Coulter Clinical Chemistry Analyzers Recalled for Software DB Error

  • Sold in 36 states
  • Sold at Beckman Coulter authorized distributors
Recalled
Added
Stryker
High RiskFDA Device

Stryker Surgical Burrs Recalled for Potential Endotoxin Contamination

  • Distributed nationwide
  • Sold at authorized medical distributors, hospital systems
  • Endotoxins contamination
Recalled
Added
Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: 4.5" Sterile Iris Scissors Recalled Due to Loose Tip Protectors

  • Distributed nationwide
  • Sold at Medical supply distributors
  • 67,811 units affected
Recalled
Added
Medium RiskFDA Device

TruDi Navigation System Multi Instrument Adapter Recalled for Inaccuracy

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

Olympus Corporation of the Americas: BICOAG Hemostasis Probe Recalled for Labeling and Connector Mismatch

  • Distributed nationwide
  • Sold at international distributors
Recalled
Added
Smiths Medical ASD
Medium RiskFDA Device

Smiths Medical ASD Inc.: Portex Hydrophobic Disc Filters Recalled for Labeling and Expiration Errors

  • Distributed nationwide
  • Sold at Direct medical distribution
  • 66,633 units affected
Recalled
Added
Getinge Usa Sales
Critical RiskFDA Device

Getinge Usa Sales Inc: Sevoflurane Vaporizers Recalled for Potential Hydrogen Fluoride Exposure

  • Sold in 7 states
  • Sold at Getinge Usa Sales Inc
  • Hydrogen fluoride contamination
Recalled
Added
Insulet
High RiskFDA Device

Omnipod 5 iOS App Recalled for Insulin Over-Delivery Risk

  • Distributed nationwide
  • Sold at Apple App Store
  • 122,823 units affected
Recalled
Added
Philips Respironics
High RiskFDA Device

Philips Respironics, Inc.: Trilogy Evo Ventilators Recalled for Missing Safety Contraindications

  • Sold in 48 states
  • Sold at Authorized medical distributors, Healthcare facilities
  • 100,126 units affected
Recalled
Added
Biocartis Nv
Medium RiskFDA Device

Biocartis Idylla Instruments Recalled for False-Positive Test Results

  • Sold in 5 states
  • Sold at Clinical laboratories, Medical distributors
Recalled
Added
GVS TM
Medium RiskFDA Device

SQ40S Blood Transfusion Filters Recalled for Sterility Concerns

  • Sold in 28 states
  • Sold at Healthcare facilities, Medical distributors
Recalled
Added
Bard Peripheral Vascular
Medium RiskFDA Device

Bard Peripheral Vascular Inc: Mission Core Biopsy Instrument Kits Recalled for Fitting and Access Issues

  • Sold in 52 states
  • Sold at Authorized medical distributors
  • 1,243,937 units affected
Recalled
Added
Raye's
High RiskFDA Device

Raye's Inc.: SW Bari Lift & Transfer Hoist Recalled for Structural and Safety Defects

  • Distributed nationwide
  • Sold at authorized medical device distributors
Recalled
Added
Sysmex America
Medium RiskFDA Device

Sysmex PS-10 Sample Preparation System Recalled for False Lab Results

  • Distributed nationwide
  • Sold at Sysmex America, Inc.
Recalled
Added
MICROVENTION
Medium RiskFDA Device

FRED 27 and FRED X 27 Flow Diverters Recalled for Improper Device Opening

  • Sold in 8 states
  • Sold at Clinical medical centers, Authorized neurovascular distributors
Recalled
Added
Medtronic Neuromodulation
Medium RiskFDA Device

Medtronic Recharger Kits Recalled for Failure to Start Recharging Sessions

  • Sold in 18 states
  • Sold at Authorized Medical Distributors, Hospitals
Recalled
Added
Integra LifeSciences
Medium RiskFDA Device

Integra LifeSciences Corp.: AURORA Surgiscope System Recalled for Potential Sheath Damage and Bleeding Risk

  • Sold in New York, Ohio, District of Columbia
  • Sold at Integra LifeSciences Corp.
Recalled
Added
CareFusion 303
Medium RiskFDA Device

BD Alaris Pump Module 8100 Recalled for Network Connectivity Issues

  • Sold in 4 states
  • Sold at Hospital networks, Medical device distributors
Recalled
Added
Critical RiskFDA Device

Medline Intubation Kits Recalled for Defective Endotracheal Tubes

  • Sold in California
  • Sold at Medical Supply Distributors
Recalled
Added
Barco N.V.
Medium RiskFDA Device

Barco NexxisOR System Components Recalled for Display and Signal Failures

  • Sold in Texas, Ohio
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Maquet Cardiovascular
Medium RiskFDA Device

Maquet Cardiovascular, LLC: Acrobat-i Vacuum Positioners Recalled Due to Arm Locking Failure

  • Distributed nationwide
  • Sold at hospital distributors, Maquet Cardiovascular LLC
Recalled
Added
Medium RiskFDA Device

Olympus Quest Spectrum 3 Imaging System Recalled for Interference Risk

  • Sold in Ohio
  • Sold at Olympus Corporation of the Americas
Recalled
Added
Aesculap Implant Systems
Medium RiskFDA Device

Aesculap Implant Systems LLC: Neuroendoscopy Trocar Recalled for Obstructed Visual Field Risk

  • Sold in 9 states
  • Sold at Direct distribution
Recalled
Added