Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(229)Monitoring Devices(255)Diagnostic Equipment(818)Home Healthcare(217)Contact Lenses & Vision(17)Surgical Equipment(896)

2,690 recalls

per page
ReCor Medical
Medium RiskFDA Device

Paradise Ultrasound Renal Denervation Catheters Recalled for Scrapped Product

  • Sold in 9 states
  • Sold at Direct distribution to healthcare facilities
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed Automated Impella Controller Recalled for Delayed Alarms

  • Distributed nationwide
  • Sold at Direct from manufacturer, Authorized medical device distributors
Recalled
Added
Stryker Communications
Medium RiskFDA Device

Stryker CHROMOPHARE Softlit Ring Surgical Light System Recalled for Fall Risk

  • Distributed nationwide
  • Sold at Stryker Communications, authorized medical device distributors
Recalled
Added
Medline Industries
Medium RiskFDA Device

Medline ENFit G-Tube Connectors Recalled for Potential Leakage

  • Distributed nationwide
  • Sold at Medline Industries, Medical distributors
  • 660,829 units affected
Recalled
Added
Medium RiskFDA Device

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  • 20,389 units affected
Recalled
Added
Mentor Texas
Medium RiskFDA Device

Mentor Breast Tissue Expanders Recalled for Dull or Breaking Needles

  • Distributed nationwide
  • Sold at Hospital supply chains, Medical device distributors +1 more
Recalled
Added
Medium RiskFDA Device

Olympus SOLTIVE SuperPulsed Laser Systems Recalled for Fire and Smoke Risk

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Synthes (USA) Products
Medium RiskFDA Device

Synthes Bone Taps Recalled for Incorrect Threading

  • Sold in 21 states
  • Sold at Medical distributors, Hospitals
Recalled
Added
SUMMA THERAPEUTICS
Medium RiskFDA Device

Finesse BTK Multicath Balloon Catheters Recalled for Potential Balloon Burst

  • Sold in New Jersey, Florida
  • Sold at Authorized medical distributors
Recalled
Added
Intuitive Surgical
Medium RiskFDA Device

da Vinci S and Si Surgical Instruments Recalled for Broken Grip Cables

  • Sold in 20 states
  • Sold at Authorized Medical Device Distributors, Intuitive Surgical Direct Sales
  • Increased complaints for broken/frayed grip cables (specific counts not provided in description).
Recalled
Added
Intuitive Surgical
Medium RiskFDA Device

da Vinci Surgical Instruments Recalled for Frayed or Broken Cables

  • Sold in 24 states
  • Sold at Authorized Medical Distributors, Direct Hospital Sales
  • Increased complaints regarding frayed or broken pitch cables.
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed, Inc.: Increased risk of purge leaks with Generation 1 purge cassettes.

  • 33,107 units affected
Recalled
Added
Baxter Healthcare
Critical RiskFDA Device

Baxter Volara Respiratory System Circuit Recalled for Barotrauma Risk

  • Sold in Florida
  • Sold at Baxter Healthcare Corporation
Recalled
Added
Civco Medical Instruments
Medium RiskFDA Device

Civco eTRAX Needle Sensors Recalled for Needle Tip Identification Error

  • Sold in Ohio, Pennsylvania, Washington
  • Sold at Medical facilities, Specialty medical distributors
Recalled
Added
Cardinal Health 200
Medium RiskFDA Device

Cardinal Health Monoject Tuberculin Syringes Recalled for Mislabeling

  • Distributed nationwide
  • Sold at Authorized medical distributors
  • 198,900 units affected
Recalled
Added
GE Healthcare
Medium RiskFDA Device

GE Healthcare SIGNA Premier MR Scanners Recalled for Risk of Projectile Injury

  • Sold in 9 states
  • Sold at GE Healthcare LLC
  • Ferrous (steel) fittings contamination
Recalled
Added
Philips Respironics
Critical RiskFDA Device

Philips Respironics Trilogy Evo Ventilators Recalled for Alarm Delay

  • Distributed nationwide
  • Sold at Durable Medical Equipment (DME) providers, Hospitals +1 more
  • 113,717 units affected
Recalled
Added
Oxoid Australia Pty
Medium RiskFDA Device

Oxoid Microbact Listeria 12L Identification Kits Recalled for Inaccurate Results

  • Sold in Georgia, California
  • Sold at Laboratory suppliers, Thermo Fisher Scientific
Recalled
Added
Burlington Medical
Medium RiskFDA Device

Burlington Medical Radiation Protection Products Recalled for Shielding Defect

  • Distributed nationwide
  • Sold at authorized distributors, healthcare facilities +1 more
  • 96,395 units affected
Recalled
Added
Medline Industries
Medium RiskFDA Device

Medline Medical Kits Recalled for Detachable Biopsy Valve Fragments

  • Sold in 13 states
  • Sold at Authorized Medical Distributors, Hospitals +1 more
  • Rubber fragments contamination
Recalled
Added
Medtronic MiniMed
High RiskFDA Device

Medtronic MiniMed Insulin Pumps Recalled for Insulin Delivery Risk

  • Sold in 53 states
  • Sold at Authorized Medical Device Distributors, Medtronic MiniMed, Inc.
  • Severe hypoglycemia, altered mental status, seizure, coma, death, severe hyperglycemia, dehydration, and diabetic ketoacidosis reported.
Recalled
Added
Tornier
Medium RiskFDA Device

Tornier HRS Max Shoulder Replacement Parts Recalled for Mislabeling

  • Sold in 32 states
  • Sold at Tornier, Inc., Medical device distributors
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

MicroScan Neg MIC 3J Diagnostic Panels Recalled for Dosing Error

  • Distributed nationwide
  • Sold at International distribution, Authorized distributors in Japan
Recalled
Added
XTANT Medical
Medium RiskFDA Device

XTANT Medical Xpress Pedicle Screw System Recalled for Mislabeled Length

  • Sold in Oregon
  • Sold at hospitals, surgical centers
Recalled
Added