Go Backs

Surgical Equipment

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

890 recalls

per page
THERAKOS DEVELOPMENT
Medium RiskFDA Device

Cellex Photopheresis Kit Recalled for Centrifuge Bowl Dislodgment Risk

  • Distributed nationwide
  • Sold at Specialty medical distributors, Direct to healthcare facilities
Recalled
Added
Clariance-SAS
Medium RiskFDA Device

Elegance Anterior Cervical Plates Recalled Due to Presence of Metal Burrs

  • Sold in 4 states
  • Sold at hospitals, medical distributors
  • Metal fragments contamination
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
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
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
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
Cook
Medium RiskFDA Device

Various Cook Medical Devices Recalled for Incorrect Expiration Dates

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospitals +1 more
  • 12,434 units affected
Recalled
Added
Iotamotion
Low RiskFDA Device

Iotamotion Inc: iotaSOFT Plus Drive Unit Recalled for Incorrect Labeling

  • Sold in Iowa
  • Sold at Authorized medical distributors
Recalled
Added
Hologic
Medium RiskFDA Device

Hologic Sizer Set Sterilization Trays Recalled for Incorrect Instructions

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

HotDog and Hillrom Temperature Controllers Recalled for System Power Errors

  • Distributed nationwide
  • Sold at Augustine Surgical Inc., Hillrom +1 more
Recalled
Added
Medium RiskFDA Device

Mckesson Medical-Surgical Inc. Corporate Office: Coviden Monoject 60ml Syringes Recalled for Distribution of Quarantined Product

  • Sold in New Jersey
  • Sold at McKesson Medical-Surgical Inc.
Recalled
Added
Avanos Medical
Medium RiskFDA Device

Avanos Medical, Inc.: COOLIEF RF Generators Recalled for F100 and F101 System Faults

  • Sold in 16 states
  • Sold at Avanos Medical, Inc. direct distribution
Recalled
Added
Stryker
Medium RiskFDA Device

Stryker Corporation: Stryker iBur Medical Devices Recalled for Potential Thermal Injury Risk

  • Distributed nationwide
  • Sold at Stryker Corporation authorized distributors, Direct medical sales channels
  • 23,330 units affected
Recalled
Added
Advanced Research Medical
Medium RiskFDA Device

Advanced Research Medical, LLC: Lumbar Interbody Fusion System Flexible Curette Blade Recalled for Shearing Risk

  • Sold in Minnesota
  • Sold at Advanced Research Medical, LLC
  • Metal fragments contamination
Recalled
Added
Accuray
High RiskFDA Device

Accuray CyberKnife Treatment Systems Recalled for Mechanical Failure Risk

  • Distributed nationwide
  • Sold at authorized medical device distributors, specialty healthcare systems
Recalled
Added
Asensus Surgical
Critical RiskFDA Device

Asensus Surgical Inc: Senhance Surgical System Recalled Due to Uncontrolled Robotic Arm Motion

  • Sold in 5 states
  • Sold at Hospitals, Surgical Centers
Recalled
Added
ROi CPS
Critical RiskFDA Device

ROi CPS LLC: Surgical Convenience Kits Recalled Due to Recalled Component

  • Sold in Louisiana
  • Sold at Direct distribution
Recalled
Added
QUANTUM SURGICAL SAS
Medium RiskFDA Device

QUANTUM SURGICAL SAS: EPIONE Device Recalled Due to Rust on Needle Guide Component

  • Sold in Florida
  • Sold at Direct distribution
  • Rust contamination
Recalled
Added
Spectrum Medical
Medium RiskFDA Device

Spectrum Medical Ltd.: Quantum Perfusion Roller Pumps Recalled for Mechanical Locking Failure

  • Sold in 18 states
  • Sold at Hospitals and medical facilities
Recalled
Added
VIRTUAL INCISION
Medium RiskFDA Device

MIRA Surgical System Recalled for Software Lag and Motion Interruption

  • Sold in California, Florida, Nebraska
  • Sold at Virtual Incision Corporation
Recalled
Added
Innomed
Medium RiskFDA Device

Innomed, Inc.: Cup Removal Starter Instrument Recalled for Incorrect Blade Attachment

  • Sold in 11 states
  • Sold at Innomed, Inc.
Recalled
Added
Numed
Medium RiskFDA Device

BIB Balloon in Balloon Dilatation Catheter Recalled for Labeling Error

  • Sold in Pennsylvania
  • Sold at Specialized medical distributors
Recalled
Added