Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(226)Monitoring Devices(265)Diagnostic Equipment(820)Home Healthcare(225)Contact Lenses & Vision(17)Surgical Equipment(893)

2,693 recalls

per page
Lucid Diagnostics
Medium RiskFDA Device

Lucid Diagnostics, Inc.: EsophaCap Sponges Recalled Due to Risk of Detachment During Removal

  • Sold in Minnesota, Maryland
  • Sold at Clinical sites, Distributors
Recalled
Added
Medium RiskFDA Device

Olympus Electrosurgical Generator Recalled for Audio Buffer System Error

  • Distributed nationwide
  • Sold at Authorized medical device distributors
Recalled
Added
Beaver Visitec International
Medium RiskFDA Device

Beaver Visitec International, Inc.: BVI CustomEyes Procedure Packs Recalled Due to Faulty Syringes

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Hospitals +1 more
  • 38,878 units affected
Recalled
Added
Boston Scientific
Critical RiskFDA Device

Boston Scientific Corporation: Expo 5F Angiographic Catheters Recalled for Potential Lining Detachment

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
  • 1,048,538 units affected
Recalled
Added
Family Dollar Stores
Medium RiskFDA Device

Family Dollar Stores, Llc.: Various Health and Oral Care Products Recalled Due to Temperature Mismanagement

  • Sold in 23 states
  • Sold at Family Dollar
  • 329,044 units affected
Recalled
Added
Medtronic Perfusion Systems
Medium RiskFDA Device

Medtronic Perfusion Systems: Medtronic Perfusion Cannulae and Accessories Recalled for Unsealed Packaging

  • Distributed nationwide
  • Sold at Hospital supply chains, Surgical centers +1 more
  • Potential microbial contamination due to unsealed packaging contamination
Recalled
Added
Baxter Healthcare
Medium RiskFDA Device

Baxter MiniCap PD Transfer Sets Recalled for Connector Separation Risk

  • Distributed nationwide
  • Sold at Baxter Healthcare Corporation, Medical distributors
  • An increase in complaints related to connector separation was reported; specific injury counts not provided.
Recalled
Added
Carefusion 2200
Medium RiskFDA Device

Carefusion 2200 Inc: Snowden-Pencer Endoscopic Surgical Devices Recalled for Breaking Knobs

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Abiomed
Critical RiskFDA Device

Abiomed, Inc.: Automated Impella Controller (AIC) Recalled for Heart Pump Detection Failure

  • Distributed nationwide
  • Sold at Hospitals, Specialty Healthcare Facilities
  • Critical risk reported; no specific injury count provided in dataset.
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter UIBC Assay Kits Recalled for Inaccurate Test Results

  • Sold in 9 states
  • Sold at Authorized Medical Distributors, Direct Sales to Laboratories
  • 56,696 units affected
Recalled
Added
B. Braun Medical
High RiskFDA Device

B. Braun Medical, Inc.: IV Administration Pump Sets Recalled for Backcheck Valve Malfunction

  • Distributed nationwide
  • Sold at Hospital supply channels, Medical device distributors
  • Reports of patient injuries involving adverse drug reactions and product malfunctions with loss of medication/blood.
Recalled
Added
GET TESTED INTERNATIONAL AB
Medium RiskFDA Device

Get Tested International Diagnostic Test Kits Recalled for Lack of FDA Clearance

  • Distributed nationwide
  • Sold at GET TESTED INTERNATIONAL AB
  • 25,201 units affected
Recalled
Added
Covidien
Medium RiskFDA Device

Covidien: Invos Sensor Cables Recalled for Connector Defects and System Errors

  • Sold in 25 states
  • Sold at Medical distributors, Covidien direct sales
Recalled
Added
LSL Healthcare
Medium RiskFDA Device

LSL Healthcare Central Line Dressing Kits Recalled for Packaging Seal Defect

  • Sold in Idaho
  • Sold at Medical distributors
Recalled
Added
Applied Medical Technology
Medium RiskFDA Device

Applied Medical Technology NutraGlide Nasal Feeding Tubes Recalled for Occlusion

  • Sold in 4 states
  • Sold at Hospitals, Medical Supply Distributors +1 more
Recalled
Added
Atrium Medical
Medium RiskFDA Device

Atrium Medical Corporation: Ocean, Oasis, and Express Chest Drains Recalled for Missing Instructions

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
  • 550,646 units affected
Recalled
Added
Critical RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Medical Kits and Trays Recalled for Possible Lack of Sterility

  • Distributed nationwide
  • Sold at Hospitals, Healthcare facilities +1 more
  • Non-sterile saline, Non-sterile water contamination
Recalled
Added
Fresenius Kabi USA
Critical RiskFDA Device

Fresenius Kabi USA, LLC: Ivenix Infusion System Recalled Due to Potential Fluid Valve Failure

  • Sold in 5 states
  • Sold at authorized healthcare distributors, hospitals
Recalled
Added
Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

  • 813,917 units affected
Recalled
Added
Ortho-Clinical Diagnostics
Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: VITROS Laboratory Systems Recalled for Software Issues and Screen Freezes

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Direct sales to hospitals and laboratories
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips IntelliVue Patient Monitors Recalled for Failure to Alarm

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Hospital supply chains +1 more
  • 1,913,441 units affected
Recalled
Added
Pulmonx
Medium RiskFDA Device

Pulmonx, Corp.: Zephyr Endobronchial Valves Recalled for Incorrect Expiration Dates

  • Sold in 22 states
  • Sold at Specialty medical distributors, Hospitals
Recalled
Added
Alcon Research
Medium RiskFDA Device

Alcon Research LLC: NGENUITY 3D Surgical Image Software Recalled for Incorrect Vision Correction

  • Sold in 34 states
  • Sold at Authorized Medical Distributors, Surgical Centers
Recalled
Added
Medium RiskFDA Device

Jiangsu Shenli Medical Production Co., Ltd.: Medline, GMAX, and Wolf Medical Piston Syringes Recalled for Unauthorized Sizes

  • Sold in 6 states
  • Sold at Authorized cargo distributors, Medline +3 more
  • 108,025,840 units affected
Recalled
Added