Go Backs

Surgical Equipment

AllImplants & Prosthetics(227)Monitoring Devices(261)Diagnostic Equipment(819)Home Healthcare(220)Contact Lenses & Vision(17)Surgical Equipment(896)

896 recalls

per page
MICROVENTION
Medium RiskFDA Device

MICROVENTION INC.: HydroPearl Microspheres Recalled for Manufacturing Process Violations

  • Sold in 7 states
  • Sold at MicroVention Inc., Medical distributors
Recalled
Added
Intuitive Surgical
Medium RiskFDA Device

Ion Vision Probe Bags Recalled for Potential Sterile Seal Compromise

  • Sold in 51 states
  • Sold at Intuitive Surgical, Inc.
  • 110,580 units affected
Recalled
Added
O&M HALYARD
Medium RiskFDA Device

Halyard Orthopedic and Universal Surgical Drape Packs Recalled for Sterility Risk

  • Sold in Georgia, Alabama, Pennsylvania
  • Sold at Medical supply distributors, Healthcare facilities
Recalled
Added
Integra LifeSciences
High RiskFDA Device

Integra LifeSciences Corp.: Bactiseal EVD Catheter Sets Recalled for Possible Compromised Sterility

  • Sold in Texas
  • Sold at Direct distribution
Recalled
Added
Wilson-Cook Medical
Medium RiskFDA Device

Cook Medical Hemospray Endoscopic Hemostats Recalled for Material Defects

  • Distributed nationwide
  • Sold at Government distribution, Military distribution
  • Nonconforming raw materials contamination
Recalled
Added
Cosmedent
Medium RiskFDA Device

Cosmedent, Inc.: FlexiCup Composite Finishing System Recalled for Crumbling Material

  • Distributed nationwide
  • Sold at Direct sales, Dental distributors
  • Reports were received that the elastomer cup material is crumbling; no specific injury counts provided.
Recalled
Added
IDS
Medium RiskFDA Device

IDS Smaxel Fractional CO2 Laser Recalled for Missing Safety Labels

  • Distributed nationwide
  • Sold at Medical device distributors, Specialty retailers
Recalled
Added
Zimmer Biomet Spine
Medium RiskFDA Device

Zimmer Biomet Spine Inc.: Spinal Fixation System Screws Recalled for Incorrect Size Markings

  • Sold in Minnesota, Nebraska
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Medium RiskFDA Device

Olympus Corporation of the Americas: OES 4000 Hysteroscope Recalled for Liquid Ingress and Foggy Image Risks

  • Sold in New York
  • Sold at Olympus Corporation of the Americas
Recalled
Added
Wolf, Henke Sass
Medium RiskFDA Device

Wolf, Henke Sass, Gmbh: Henke-Ject-2 Part Luer Sterile Syringes Recalled for Compromised Sterility

  • Distributed nationwide
  • Sold at authorized medical distributors
  • 216,000 units affected
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien: Valleylab FT10 Energy Platforms Recalled for Software-Related System Failure

  • Distributed nationwide
  • Sold at Authorized Medtronic/Covidien distributors
  • 47,901 units affected
Recalled
Added
Critical RiskFDA Device

MicroMyst Applicator Recalled for Lack of Sterility Assurance

  • Distributed nationwide
  • Sold at authorized medical distributors
Recalled
Added
Mazor Robotics
Medium RiskFDA Device

Mazor X Robotic Guidance Systems Recalled for Software Positioning Errors

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Contego Medical
Medium RiskFDA Device

Neuroguard IEP Carotid Stent Systems Recalled for Filter Deployment Failure

  • Sold in 23 states
  • Sold at authorized medical distributors, hospitals +1 more
Recalled
Added
Merit Medical Systems
Medium RiskFDA Device

Merit Medical PhD Hemostasis Valves Recalled for Potential Leakage

  • Sold in 49 states
  • Sold at Medical Supply Distributors
  • 217,141 units affected
Recalled
Added
Straumann USA
Medium RiskFDA Device

Straumann Plus Initial Drill Recalled for Missing Laser Depth Engraving

  • Sold in 16 states
  • Sold at authorized dealers, medical distributors
Recalled
Added
DeRoyal Industries
Medium RiskFDA Device

DeRoyal Suction Connector Tubing Recalled for Potential Suction Failure

  • Sold in 5 states
  • Sold at medical distributors
Recalled
Added
Medline Industries
Medium RiskFDA Device

Medline Adult Anesthesia Sets Recalled Due to Leaking IV Components

  • Sold in Missouri
  • Sold at Authorized medical distributors
  • Customer reports of leaking; no specific injuries quantified.
Recalled
Added
Hologic
Medium RiskFDA Device

Brevera Breast Biopsy Disposable Needles Recalled for Particulate Contamination

  • Distributed nationwide
  • Sold at Medical distributors, Direct from manufacturer
  • Particulates contamination
Recalled
Added
B.Braun Medical S.A.S.
Medium RiskFDA Device

Celsite Babyport Sets Recalled for Risk of Vessel Damage

  • Sold in Pennsylvania
  • Sold at Medical device distributors
Recalled
Added
Medium RiskFDA Device

Stryker Leibinger GmbH & Co. KG: Cranial Skeleton Mesh Recalled Due to Mislabeled Packaging

  • Distributed nationwide
  • Sold at Medical distributors, Direct hospital sales
Recalled
Added
Alcon Research, LLC: Alcon Custom Paks Recalled for Cannula Defects and Particulates
Medium RiskFDA Device

Alcon Research, LLC: Alcon Custom Paks Recalled for Cannula Defects and Particulates

  • Sold in 36 states
  • Sold at Vantage Outsourcing, VA Medical Centers +7 more
  • Particulates, Residue contamination
Recalled
Added
Biosense Webster
Critical RiskFDA Device

VARIPULSE Ablation Catheters Recalled for Risk of Neurovascular Events

  • Sold in 10 states
  • Sold at Medical facilities, Hospitals +1 more
  • Observed trend of neurovascular events; specific injury count not provided.
Recalled
Added
Medtronic Navigation
Critical RiskFDA Device

Medtronic Navigation, Inc.: Stealth S8 Clinical Software Recalled for Critical Navigation Display Errors

  • Distributed nationwide
  • Sold at Medtronic Navigation, Inc., authorized medical distributors
Recalled
Added