Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(229)Monitoring Devices(257)Diagnostic Equipment(818)Home Healthcare(218)Contact Lenses & Vision(17)Surgical Equipment(896)

2,690 recalls

per page
Hologic
Medium RiskFDA Device

Aptima HPV Assay Recalled for Potential False Negative Results

  • Sold in 9 states
  • Sold at Clinical laboratories, Healthcare facilities
Recalled
Added
ConvaTec
Medium RiskFDA Device

Convatec EsteemBody Drainable Pouches Recalled for Potential Leaks

  • Distributed nationwide
  • Sold at Medical supply distributors
Recalled
Added
LeMaitre Vascular
Medium RiskFDA Device

Artegraft Vascular Graft Recalled for Packaging and Labeling Mix-Up

  • Sold in Illinois
  • Sold at Medical distributors
Recalled
Added
Diagnostica Stago
Medium RiskFDA Device

Diagnostica Stago STA Liatest D-Di Kits Recalled for Inaccurate Results

  • Distributed nationwide
  • Sold at Professional laboratory suppliers
  • 34,000 units affected
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

MicroScan Neg MIC 56 Panels Recalled for Potential Contamination

  • Sold in 12 states
  • Sold at Direct from manufacturer, Laboratory distributors
  • Unknown biological contamination contamination
Recalled
Added
GE Medical Systems
Medium RiskFDA Device

Imactis CT-Navigation Systems Recalled for Needle Trajectory Issue

  • Distributed nationwide
  • Sold at GE Medical Systems, Authorized Medical Device Distributors
Recalled
Added
Erbe USA
Critical RiskFDA Device

Erbe Flexible Cryoprobes Recalled for Rupture and Bursting Risk

  • Distributed nationwide
  • Sold at hospitals, surgical centers +1 more
  • 40,952 units affected
Recalled
Added
Medium RiskFDA Device

Olympus Endoscope Valves and Reprocessors Recalled for Compatibility Defect

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Direct Sales
  • Biological Contaminants contamination
Recalled
Added
Navajo Manufacturing
Critical RiskFDA Device

Handy Solutions Heating Pads Recalled for Burn and Fire Risk

  • Sold in 7 states
  • Sold at Retailers in CA, MS, FL, IN, LA, VA, TX
  • 28,457 units affected
Recalled
Added
I.T.S.
Medium RiskFDA Device

I.T.S. GmbH Orthopedic Plates and Screws Recalled for MRI Safety Risks

  • Sold in 28 states
  • Sold at Authorized Medical Device Distributors, Surgical Centers +1 more
  • 84,406 units affected
Recalled
Added
Medtronic MiniMed
Medium RiskFDA Device

Medtronic MiniMed, Inc.: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

  • 26,851 units affected
Recalled
Added
Koven Technology
Medium RiskFDA Device

BiDop 3 Pocket Doppler Recalled for Unapproved Fetal Use Labeling

  • Sold in 16 states
  • Sold at Authorized distributors, Medical equipment suppliers
Recalled
Added
Medium RiskFDA Device

TECNIS Eyhance IOL Recalled for Lens Unfolding Issues

  • Sold in 11 states
  • Sold at Authorized medical distributors, Surgical centers
Recalled
Added
Orthalign
Medium RiskFDA Device

Lantern Knee System Drill Plates Recalled for Incorrect Bone Cut Depth

  • Sold in Utah
  • Sold at Hospital systems, Surgical centers
Recalled
Added
Straumann USA
Medium RiskFDA Device

Straumann Custom Abutments Recalled for Material Manufacturing Mix-up

  • Sold in 10 states
  • Sold at Nationwide dental practitioners, Specialty dental clinics
Recalled
Added
Philips Ultrasound
Low RiskFDA Device

Philips Ultrasound Transducers Recalled for Labelling Clarification

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Direct Sales
Recalled
Added
Tandem Diabetes Care
Medium RiskFDA Device

Tandem Insulin Pumps Recalled for Czech User Guide Translation Errors

  • Sold at International distributors
Recalled
Added
Medium RiskFDA Device

Olympus Cutting Forceps Recalled for Jaw Breaking Risk

  • Distributed nationwide
  • Sold at Olympus Corporation of the Americas, Surgical equipment distributors
Recalled
Added
Philips Respironics
Critical RiskFDA Device

Philips Trilogy Evo Ventilators Recalled for Volume Discrepancy

  • Distributed nationwide
  • Sold at Medical equipment distributors, Healthcare providers
  • 454,868 units affected
Recalled
Added
BD KIESTRA LAB AUTOMATION
Medium RiskFDA Device

BD Kiestra ReadA Lab Automation Recalled for Software Connectivity Issue

  • Sold in 6 states
  • Sold at Direct from manufacturer
Recalled
Added
Medium RiskFDA Device

Embrace Shoulder Instruments Drill Towers Recalled for Mismatched Article Numbers

  • Sold in 15 states
  • Sold at Authorized surgical distributors
Recalled
Added
Medline Industries
High RiskFDA Device

Puracol and Puracol Plus Collagen Wound Dressings Recalled for Endotoxins

  • Distributed nationwide
  • Sold at Medical supply distributors
  • Endotoxins contamination
Recalled
Added
Medium RiskFDA Device

Atellica CH Enzymatic Hemoglobin A1c Recalled for Inaccurate Results

  • Distributed nationwide
  • Sold at Clinical laboratories, Hospitals
  • 21,291 units affected
Recalled
Added
Ultradent Products
Medium RiskFDA Device

Jiffy Original Composite Polisher Cups Recalled for Crumbling Risk

  • Sold in 31 states
  • Sold at Dental supply distributors
Recalled
Added