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)

2,688 recalls

per page
DATEX--OHMEDA
Critical RiskFDA Device

GE Giraffe OmniBed Incubators Recalled for Loose Warmer Heater Door Screws

  • Distributed nationwide
  • Sold at GE HealthCare authorized distributors
Recalled
Added
Boston Scientific
Medium RiskFDA Device

Boston Scientific Corporation: Guider Softip Guide Catheters Recalled for Incorrect Tip Curve Shape

  • Sold in Indiana
  • Sold at Boston Scientific Corporation, Stryker Neurovascular +1 more
  • 57,312 units affected
Recalled
Added
Medium RiskFDA Device

BD Insyte Autoguard IV Catheters Recalled for Needle Retraction Failure

  • Sold in 42 states
  • Sold at Hospitals, Medical Supply Distributors
Recalled
Added
Edan Diagnostics: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Medium RiskFDA Device

Edan Diagnostics: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  • 70,511 units affected
Recalled
Added
Bard Peripheral Vascular
Medium RiskFDA Device

Bard Peripheral Vascular CV Catheter Trays Recalled for Sterile Barrier Damage

  • Sold in 48 states
  • Sold at Hospital suppliers, Medical device distributors
  • 14,935 units affected
Recalled
Added
Encore Medical
Medium RiskFDA Device

EMPOWR 3D Knee Tibial Inserts Recalled for Packaging Discrepancy

  • Sold in 18 states
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Philips Magnetic Resonance (MR) Systems Recalled for Fire Risk

  • Distributed nationwide
  • Sold at specialty medical equipment distributors, direct sales to hospitals
Recalled
Added
Medline Industries
Medium RiskFDA Device

Medline Procedure Kits Recalled for Strykeflow 2 Suction Irrigator Smoke Risk

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct from Medline Industries
  • 60,117 units affected
Recalled
Added
Aju Pharm
Medium RiskFDA Device

Fixone, Genesis, and AlternatiV+ Surgical Anchors Recalled for Device Failure

  • Sold in California, Puerto Rico
  • Sold at Hospitals, Surgical centers +1 more
Recalled
Added
SUREPULSE MEDICAL
Low RiskFDA Device

Surepulse VS Cap Recalled for Incorrect Sizing Guide

  • Sold in Connecticut, Texas
  • Sold at Hospital suppliers, Medical device distributors
Recalled
Added
Life Technologies
Medium RiskFDA Device

Life Technologies Corporation: Torrent Suite Dx Software Recalled for Cyber Vulnerability and Data Alteration

  • Sold in 5 states
  • Sold at Life Technologies Corporation
Recalled
Added
Spacelabs Healthcare
Medium RiskFDA Device

Spacelabs Eclipse PRO and Mini Holter Recorders Recalled for Serial Number Errors

  • Sold in 22 states
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • 14,981 units affected
Recalled
Added
Elekta
Medium RiskFDA Device

Leksell GammaPlan Treatment Planning Software Recalled for Radiation Risk

  • Sold in 32 states
  • Sold at Direct sales to hospitals and radiotherapy centers
Recalled
Added
Boston Scientific
Medium RiskFDA Device

Boston Scientific Artificial Urinary Sphincter Components Recalled for Mislabeled Packaging

  • Sold in 15 states
  • Sold at Boston Scientific Corporation
Recalled
Added
Merit Medical Systems
Medium RiskFDA Device

Merit Medical Systems, Inc.: Medical Convenience Kits Recalled Due to Defective Plastic Syringes

  • Sold in 51 states
  • Sold at Direct distribution to healthcare facilities
  • 2,890,251 units affected
Recalled
Added
Canon Medical System, USA
High RiskFDA Device

Canon Vantage Galan and Titan MRI Systems Recalled for Venting Defect

  • Sold in 19 states
  • Sold at Authorized Medical Device Distributors, Canon Medical Systems direct sales
Recalled
Added
Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Various Medical Kits Recalled for Breach of Sterility Risk

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Medline Industries +1 more
  • 1,158,478 units affected
Recalled
Added
Medium RiskFDA Device

Stryker Sustainability Solutions: Tourniquet Cuffs Recalled for Mislabeling and Incorrect Port Configuration

  • Sold in 6 states
  • Sold at Healthcare facilities, Hospitals
Recalled
Added
Medium RiskFDA Device

Medline Reprocessed Surgical Sealers and Shears Recalled for Incomplete Seals

  • Distributed nationwide
  • Sold at authorized medical distributors, Medline Industries
Recalled
Added
Draeger
Critical RiskFDA Device

Draeger SafeStar and TwinStar Breathing Filters Recalled for Faulty CO2 Monitoring

  • Sold in 30 states
  • Sold at Medical distributors, Direct hospital sales
  • 11,949,459 units affected
Recalled
Added
B Braun Medical
Medium RiskFDA Device

B. Braun IV Administration Sets Recalled for Medication Backflow and Occlusion

  • Distributed nationwide
  • Sold at B. Braun Medical Inc., Authorized Medical Device Distributors
  • 93,637,192 units affected
Recalled
Added
Instrumentation Laboratory
Medium RiskFDA Device

ACL Elite Analyzers Recalled to Remove Specific Test Definitions

  • Distributed nationwide
  • Sold at Clinical hemostasis laboratories, Hospitals
Recalled
Added
Unomedical A/S
Medium RiskFDA Device

Unomedical A/S: Neria Soft Infusion Sets Recalled for Incorrect Instructions for Use

  • Sold in Florida
  • Sold at Osted
  • 10,770 units affected
Recalled
Added
CooperSurgical
Medium RiskFDA Device

CooperSurgical, Inc.: H/S Elliptosphere Catheters Recalled for Potential Failure and Leakage

  • Distributed nationwide
  • Sold at hospitals, medical clinics
Recalled
Added