Device recalls 2026: the full US list

Every medical device recall the FDA has classified, from CPAP machines and insulin pumps to surgical instruments and test kits. Many device recalls are field corrections (software updates, new instructions) rather than product returns.

On record39,307latest 16 Sep 2026
This year2,0462026
Last 30 days174reported
Class I3,477most serious

Device recalls per month, last 24 months

click a bar for that month

Severity split, all years

Class I 3,477 9%Class II 34,831 89%Class III 998 3%Other/pending 1

Latest Class I device recalls

This week
ReportedClassRecallCompanyReasonWhere
CLASS IBravo CF capsule delivery device, Product Number FGS recalledGiven ImagingDevice MalfunctionNationwide
CLASS IKit: Epidural/Pain TQC 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
CLASS IKit: Single Shot Epidural 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
CLASS IEnroute Transcarotid Neuroprotection System recalledBoston ScientificOtherNationwide
CLASS IBD Needle Kit for Powered Driver recalled by Bard Access SystemsBard Access SystemsOther32 states

Latest device recalls

39,307 total
ReportedClassRecallCompanyReasonWhere
CLASS IIGetinge PVC Thoracic Catheter, Soft PVC Right Angle recalledAtrium MedicalPotency & AssayNationwide
CLASS IIProducts that contain the Pericare Wipes: *Bardex¿ I.C recalledC.R. BardOtherNationwide
CLASS IBravo CF capsule delivery device, Product Number FGS recalledGiven ImagingDevice MalfunctionNationwide
CLASS IICitric Complete Dry Citric Acid Concentrate recalledNipro Renal Soultions USAOtherNationwide
CLASS IIProducts that contain the Pericare Wipes recalled by C.R. BardC.R. BardOtherNationwide
CLASS IKit: Epidural/Pain TQC 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
CLASS IIHalyard IV Start Kit Non-Sterile recalled by Avid MedicalAvid MedicalSterilityNationwide
CLASS IKit: Single Shot Epidural 20/Cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Sterility6 states
CLASS IIAMS Convenience Kit: Dsaek Pack - RX recalledWindstone Medical PackagingDevice MalfunctionNationwide
CLASS IIMedicaLyte Bicarbonate Powder recalled by Nipro Renal Soultions USANipro Renal Soultions USAOtherNationwide

Device recalls by type

Other Medical Devices 13,778Heart & Vascular Devices 6,199Surgical Instruments 3,809Hip & Knee Implants 3,097Test Kits & Diagnostics 2,656Imaging Equipment 2,336Spinal Implants 1,157Syringes & Needles 1,060Patient Monitors 1,013Medical Software 903CPAP & Ventilators 552Infusion Pumps 546Pacemakers & Defibrillators 494Insulin Pumps & Glucose Monitors 459Masks, Gloves & PPE 447Dental Devices 426Wheelchairs, Beds & Lifts 172Contact Lenses & Eye Devices 152Breast Implants 29Hearing Aids 22

Top reasons

Companies with the most recalls

States most often named