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 record39,450latest 30 Sep 2026
This year2,1892026
Last 30 days227reported
Class I3,504most serious

Device recalls per month, last 24 months

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Severity split, all years

Class I 3,504 9%Class II 34,947 89%Class III 998 3%Other/pending 1

Latest Class I device recalls

This week
ReportedClassRecallCompanyReasonWhere
CLASS IInca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalledCooperSurgicalOtherNationwide
CLASS IImager II Angiographic Catheters M001314001 Imager recalledBoston ScientificOtherNationwide
CLASS IHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalOtherNationwide
CLASS IInca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalledCooperSurgicalOtherNationwide
CLASS IDuoGlide Short-Term Straight Dialysis Catheter recalledBard Access SystemsOther50 states

Latest device recalls

39,450 total
ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Convenience Kits: Major Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IIMedline Convenience Kits: Peds Sinus Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IISmartPath to dStream for XR and 3.0T recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
CLASS IIAchieva 1.5T, Achieva 1.5T Conversion recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
CLASS IIMedline Convenience Kits: Mfc Craniotomy Pack recalledMedline IndustriesOtherNationwide
CLASS IIPRO+ 36" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
CLASS IIPro+ Mrs Surface For Versacare, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
CLASS IIVolara System Volara, HC, NA recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIIngenia Ambition S and Ingenia Ambition recalledPhilips North AmericaDevice MalfunctionNationwide
CLASS IIHF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recalledVentec Life SystemsOtherNationwide
CLASS IIMedline convenience kits containing Healthmark Instrument recalledMedline IndustriesOtherNationwide
CLASS IIName (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalledPhilips North AmericaDevice MalfunctionNationwide
CLASS IIHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalPackaging DefectsNationwide
CLASS IIMedline Convenience Kits: Major Neuro Vch recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IInca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalledCooperSurgicalOtherNationwide
CLASS IIExtended Polyaxial Head, Attached Gimbal recalledSeaspine OrthopedicsOtherNationwide
CLASS IIPhilips EPIQ Elite Diagnostic Ultrasound System recalledPhilips UltrasoundLabeling ErrorsNationwide
CLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
CLASS IIOlympus BiCOAG Hemostasis Probe Fixed Pin Connector recalledOlympus Corporation of the AmericasOtherNationwide
CLASS IIIngenia 3.0T and Ingenia 3.0T CX recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
CLASS IIPresource Convenience Kits: KIT, Usgpiv recalled by Cardinal Health 200Cardinal Health 200Packaging DefectsNationwide
CLASS IIPowerLED 300 Concealed Lighting System recalled by Maquet SASMaquet SASOtherNationwide
CLASS IIEvolution upgrade 1.5T and Evolution upgrade 3.0T recalledPhilips North AmericaDevice MalfunctionNationwide
CLASS IIREF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 recalledVentec Life SystemsOtherNationwide
CLASS IIPearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVisionCooperVisionOtherNationwide
CLASS IImager II Angiographic Catheters M001314001 Imager recalledBoston ScientificOtherNationwide
CLASS IIPresource Convenience Kits: KIT, PRE OP recalled by Cardinal Health 200Cardinal Health 200Packaging DefectsNationwide
CLASS IIOlympus BiCOAG Hemostasis Probe Coaxial Connector recalledOlympus Corporation of the AmericasOtherNationwide
CLASS IIHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalPackaging DefectsNationwide
CLASS IIPRO+ 40" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide

Device recalls by type

Other Medical Devices 13,857Heart & Vascular Devices 6,212Surgical Instruments 3,816Hip & Knee Implants 3,110Test Kits & Diagnostics 2,658Imaging Equipment 2,341Spinal Implants 1,159Syringes & Needles 1,065Patient Monitors 1,014Medical Software 908CPAP & Ventilators 554Infusion Pumps 549Pacemakers & Defibrillators 494Insulin Pumps & Glucose Monitors 464Masks, Gloves & PPE 447Dental Devices 426Wheelchairs, Beds & Lifts 172Contact Lenses & Eye Devices 153Breast Implants 29Hearing Aids 22

Top reasons

Companies with the most recalls

States most often named