Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(226)Monitoring Devices(267)Diagnostic Equipment(820)Home Healthcare(229)Contact Lenses & Vision(17)Surgical Equipment(891)

2,693 recalls

per page
Beta Bionics
High RiskFDA Device

iLet Ace Pump Kits Recalled for Software Vulnerability and Hypoglycemia Risk

  • Sold in 40 states
  • Sold at authorized distributors
Recalled
Added
Medium RiskFDA Device

Stryker Sustainability Solution Color Cuffs Recalled for Pressure Loss

  • Sold in 41 states
  • Sold at Stryker Sustainability Solutions, Hospital Distributors
  • 56,740 units affected
Recalled
Added
Wilson-Cook Medical
Medium RiskFDA Device

Instinct Plus Endoscopic Clipping Device Recalled for Potential Malfunction

  • Sold in 50 states
  • Sold at Medical distributors, Hospitals +1 more
  • Increased complaints regarding malfunctions reported; no specific injury count provided.
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
Hospira
Medium RiskFDA Vet

Hospira Inc.: LifeShield HemoSet Recalled for Incorrect Drip Rate Components

  • Sold in 14 states
  • Sold at Direct medical distribution
Recalled
Added
Hospira
High RiskFDA Vet

Hospira Inc.: Plum A+ Infusion Pumps Recalled for Unrestricted Flow Risk

  • Sold in 20 states
  • Sold at Hospira Inc.
  • Reports of incorrect seating received; specific injury counts not provided
Recalled
Added
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
Abbott Vascular
Critical RiskFDA Device

Abbott Vascular: Absorb Bioresorbable Vascular Scaffold System Recalled for Heart Event Risks

  • Elevated rates of myocardial infarction and scaffold thrombosis compared to metallic stents
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs Multi-parameter Command Modules Recalled for Inaccurate Readings

  • Sold in 30 states
  • Sold at Authorized Spacelabs Medical Distributors
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
Merit Medical Systems
Critical RiskFDA Device

Merit Medical Sheath Introducers Recalled for Design Defect

  • Sold in 43 states
  • Sold at Medical Supply Distributors, Hospitals +1 more
  • 472,730 units affected
Updated
Recalled
Encore Medical
Medium RiskFDA Device

Encore Medical, LP: Shoulder and Knee Implants Recalled for Mislabeling

  • Sold in 11 states
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic Inc.: Protege GPS Self-Expanding Stent System Recalled for Potential Sterility Loss

  • Sold in Minnesota
  • Sold at Authorized medical distributors
Recalled
Added
Abbott Diabetes Care
Medium RiskFDA Device

Abbott Diabetes Care, Inc.: FreeStyle Libre 3 App Recalled for Potential Signal Loss on Android 13

  • Sold in 19 states
  • Sold at Authorized medical distributors, App stores
  • 45,173 units affected
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
Abiomed
Medium RiskFDA Device

Abiomed, Inc.: Automated Impella Controller Recalled for Software Issue and Connection Failure

  • Sold in 5 states
  • Sold at Abiomed, Inc.
Recalled
Added
Abiomed
Medium RiskFDA Device

Abiomed, Inc.: Automated Impella Controller (AIC) Software Update for Pump Recognition Issue

  • Distributed nationwide
  • Sold at Hospitals, Medical Facilities
Recalled
Added
Fresenius Kabi USA
Medium RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Software Recalled for Potential Over-infusion

  • Sold in 5 states
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
Fresenius Kabi USA
Medium RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Software Recalled for Fail-Stop Alarm Defect

  • Sold in Wisconsin, New Jersey
  • Sold at Specialty medical distributors
Recalled
Added
Bolton Medical
Medium RiskFDA Device

Bolton Medical Inc.: Relay Pro Thoracic Stent-Grafts Recalled for Incorrect Device Sizing

  • Sold in Arizona, Massachusetts, Texas
  • Sold at Direct distribution to hospitals and surgical centers
Recalled
Added
Vortex Surgical
Medium RiskFDA Device

Vortex Surgical Inc.: ACTU8 Adaptive Forceps Recalled Due to Residue on Device Tips

  • Sold in 5 states
  • Sold at Vortex Surgical Inc., Medical distributors
  • Unidentified residue contamination
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