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 record39,637latest 14 Oct 2026
This year2,3762026
Last 30 days242reported
Class I3,507most serious

Device recalls per month, last 24 months

click a bar for that month

Severity split, all years

Class I 3,507 9%Class II 35,121 89%Class III 1,007 3%Other/pending 2

Latest Class I device recalls

This week
ReportedClassRecallCompanyReasonWhere
CLASS IVentStar Resus Neo recalled by DraegerDraegerPackaging DefectsNationwide
CLASS IMedline Basic Homecare Beds and Medlite Homecare Beds recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IMedline Basic Homecare Beds and Medlite Homecare Beds recalledMedline IndustriesOtherNationwide
CLASS IInca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalledCooperSurgicalOtherNationwide
CLASS IImager II Angiographic Catheters M001314001 Imager recalledBoston ScientificOtherNationwide

Latest device recalls

39,637 total
ReportedClassRecallCompanyReasonWhere
CLASS IIPlastics Tray kits recalled by Avid MedicalAvid MedicalForeign MaterialNationwide
CLASS IIIPassport Series Patient Monitor recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIHeart Prep Tray kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIPack Open Heart Cfh kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IITufTex¿ Over-the-Wire Embolectomy Catheter recalledLeMaitre VascularOtherNationwide
CLASS IIIT1 Patient Monitor recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IISperm Ab Elisa (96 well plate test) recalled by DRG InternationalDRG InternationalOtherNationwide
CLASS IIIntellijoint Navigation System: Workstation G2 Configured recalledIntellijoint SurgicalDevice MalfunctionNationwide
CLASS IIAdaptable Beach Chair Beach Chair surgical patient positioner recalledQuantum OPSDevice MalfunctionNationwide
CLASS IILaparoscopic Prostatectomy kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIIBeneView Series recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIIcPM Series Patient Monitor recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIDxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalledBeckman CoulterDevice MalfunctionNationwide
CLASS IIAlphenix Infx-8000C/B5 recalled by Canon Medical System USACanon Medical System USAOtherNationwide
CLASS IIHalyard Laparoscopy Comprehensive Pack II recalledGRI Medical & Electronic TechnologyOtherNationwide
CLASS IIEndovascular Pack kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIIBeneVision Series Telemetry Monitor recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIDavinci LAP/GYN kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IISediplast; Model/Catalog Numbers recalled by Polymedco, Inc. / PolymedcoPolymedco, Inc. / Polymedco Cancer Diagnostic ProductsOtherNationwide
CLASS IIDxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalledBeckman CoulterDevice MalfunctionNationwide
CLASS IIPresource Packs containing Medtronic Microstream Components recalledCardinal Health 200Device MalfunctionIL
CLASS IIIPanorama and Telemetry Monitoring System recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIMajor Pack kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIIKit: Urinary Clean Catch 20/cs recalled by Medical Action IndustriesMedical Action Industries Inc. 306Device MalfunctionCA
CLASS IIGyn Laparoscopy/Laparotomy kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIIBeneVision N1 and N-Series Patient Monitor recalled by Mindray DS USAMindray DS USADevice MalfunctionNationwide
CLASS IIABD Hysterectomy kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIGyn Laparoscopy Pack kits recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IIRollator, Bariatric, Basic Steel, Burgundy recalledMedline IndustriesForeign MaterialNationwide
CLASS IIVerify Biological Steam Test Pack recalled by SterisSterisSterilityNationwide

Device recalls by type

Other Medical Devices 13,908Heart & Vascular Devices 6,220Surgical Instruments 3,891Hip & Knee Implants 3,111Test Kits & Diagnostics 2,663Imaging Equipment 2,347Spinal Implants 1,159Syringes & Needles 1,066Patient Monitors 1,022Medical Software 932CPAP & Ventilators 554Infusion Pumps 549Pacemakers & Defibrillators 494Insulin Pumps & Glucose Monitors 467Masks, Gloves & PPE 450Dental Devices 426Wheelchairs, Beds & Lifts 174Contact Lenses & Eye Devices 153Breast Implants 29Hearing Aids 22

Top reasons

Companies with the most recalls

States most often named