Go Backs

Medical Devices

Medical Devices product recalls

AllImplants & Prosthetics(225)Monitoring Devices(272)Diagnostic Equipment(819)Home Healthcare(232)Contact Lenses & Vision(17)Surgical Equipment(890)

2,693 recalls

per page
Philips North America
Medium RiskFDA Device

Philips MRE Scanning Systems Recalled for Accuracy Errors

  • Distributed nationwide
  • Sold at Authorized Philips medical equipment distributors, Direct sales to hospitals and clinics
Recalled
Added
Advanced Bionics
Medium RiskFDA Device

HiResolution Bionic Ear M Zn-Air Battery Paks Recalled for Battery Access Risk

  • Sold in 51 states
  • Sold at Authorized Medical Distributors, Audiology Clinics
  • 45,173 units affected
Recalled
Added
Zimmer
Medium RiskFDA Device

Disposable Mixing Bowls and Spatulas Recalled for Defective Package Seals

  • Sold in 31 states
  • Sold at Hospital suppliers, Medical device distributors
  • Ten complaints received regarding package seal issues; no specific injury counts provided.
Recalled
Added
Medtronic
High RiskFDA Device

Medtronic Sphere-9 Catheter Recalled Due to Heart Rhythm Interactions

  • Distributed nationwide
  • Sold at medical supply distributors, hospitals +1 more
  • Observations of ventricular fibrillation (VF) during therapy.
Recalled
Added
Milestone S.R.L.
Medium RiskFDA Device

Milestone VACUUM BAG SU LARGE Specimen Containers Recalled for Reagent Leakage

  • Distributed nationwide
  • Sold at authorized medical distributors
  • reagents contamination
Recalled
Added
Healthmark Industries
Medium RiskFDA Device

Mesh Style Tip Protectors Recalled for Lack of FDA Clearance

  • Distributed nationwide
  • Sold at Authorized distributors, Direct sales
  • 4,291,797 units affected
Recalled
Added
Boston Scientific
Critical RiskFDA Device

Boston Scientific Pacemakers and CRT-Ps Recalled for Software Update

  • Distributed nationwide
  • Sold at Hospitals, Medical Facilities +1 more
  • 1,404,232 units affected
Recalled
Added
Clinical Innovations
Medium RiskFDA Device

Kiwi Omni Vacuum Delivery System Recalled for Device Breakage Risk

  • Sold in 37 states
  • Sold at Hospital suppliers, Medical distributors
  • Complaints of device breakage; no specific injury counts provided.
Recalled
Added
Hologic
Medium RiskFDA Device

Genius Review Station Recalled Due to Misconfigured Display Settings

  • Distributed nationwide
  • Sold at Hologic, Inc., Authorized medical device distributors
Recalled
Added
WHILL
Critical RiskFDA Device

WHILL, INC.: WHILL Model C2 and Model F Powered Wheelchairs Recalled for Cyber Vulnerability

  • Sold in Kansas
  • Sold at authorized dealers, specialty retailers
Recalled
Added
Diversatek Healthcare
Medium RiskFDA Device

Diversatek Viper 3-Stage Balloon Dilators Recalled for Incorrect Pressure Labels

  • Sold in 19 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

Hamilton AutoLys STAR Software Recalled for Spontaneous Closures

  • Sold in North Carolina, Massachusetts
  • Sold at Foundation Medicine, Inc., Research Triangle Park Laboratory
Recalled
Added
Windstone Medical Packaging
Medium RiskFDA Device

Custom Convenience Kits Pre Op Kits Recalled for IV Set Backflow Risk

  • Sold in 4 states
  • Sold at Hospitals, Surgical centers +1 more
Recalled
Added
Remel Europe
Medium RiskFDA Device

Oxoid Agglutinating Sera Recalled for Potential Salmonella Misidentification

  • Sold in 15 states
  • Sold at Authorized laboratory distributors
Recalled
Added
Micro-X
Medium RiskFDA Device

Rover Mobile X-ray Systems Recalled Due to Generator Malfunction

  • Sold in 4 states
  • Sold at Micro-X Ltd.
Recalled
Added
LSL Healthcare
Medium RiskFDA Device

LSL Healthcare Medical Procedure Kits Recalled for Non-Sterile Alcohol Pads

  • Sold in Maryland, Illinois, Minnesota
  • Sold at LSL Healthcare Inc.
  • Non-sterile microbes contamination
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

FoundationOne CDx Sequencing Agents Recalled for False-Positive Test Results

  • Sold in Massachusetts, North Carolina
  • Sold at Foundation Medicine, Inc.
Recalled
Added
ARROW INTERNATIONAL
Medium RiskFDA Device

Arrow Catheter Kits and Needles Recalled for Defective Liquid Adhesive

  • Sold in 9 states
  • Sold at Direct medical distribution, Hospitals +1 more
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Access Total T4 Calibrator Recalled for Inaccurate Patient Test Results

  • Distributed nationwide
  • Sold at Medical laboratories, Hospitals
Recalled
Added
SurgiSmoke Solutions
Medium RiskFDA Device

Flamingo Funnel Medical Devices Recalled for Sterilization Issues

  • Sold in 13 states
  • Sold at Hospital supply chains, Medical device distributors
Recalled
Added
Medium RiskFDA Device

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Olympus Direct Sales
  • 48,999 units affected
Recalled
Added
XTANT Medical
Medium RiskFDA Device

nanOss 3D Bone Graft Substitutes Recalled for Incorrect Shelf Life

  • Sold in 9 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Davol
Medium RiskFDA Device

Avitene Ultrafoam Hemostat Recalled for Insect Fragment Contamination

  • Distributed nationwide
  • Sold at hospitals, healthcare facilities
  • Insect fragments contamination
Recalled
Added
ZOLIQUEX Adult Portable Bed Rails Recalled for Entrapment and Asphyxiation Risk
High RiskCPSC

ZOLIQUEX Adult Portable Bed Rails Recalled for Entrapment and Asphyxiation Risk

  • Distributed nationwide
  • Sold at Amazon.com
  • 16,000 units affected
Recalled
Added