Other Medical Devices recalls

13,857 medical device recalls in the other medical devices category are on file with the FDA, from 2012 to 30 Sep 2026.

Total recalls13,857since 2012
Last 12 months1,449reported
Class I1,0428% of total
Ongoing6,031latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1,042 8%Class II 12,371 89%Class III 444 3%

Why other medical devices is recalled

By year

Ongoing other medical devices recalls

6,031 active

All other medical devices recalls, newest first

13,857 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Major Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
DeviceCLASS IIMedline Convenience Kits: Peds Sinus Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
DeviceCLASS IISmartPath to dStream for XR and 3.0T recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIAchieva 1.5T, Achieva 1.5T Conversion recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIMedline Convenience Kits: Mfc Craniotomy Pack recalledMedline IndustriesOtherNationwide
DeviceCLASS IIPRO+ 36" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DeviceCLASS IIPro+ Mrs Surface For Versacare, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DeviceCLASS IIIngenia Ambition S and Ingenia Ambition recalledPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIHF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recalledVentec Life SystemsOtherNationwide
DeviceCLASS IIMedline convenience kits containing Healthmark Instrument recalledMedline IndustriesOtherNationwide
DeviceCLASS IIName (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalledPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalPackaging DefectsNationwide
DeviceCLASS IIMedline Convenience Kits: Major Neuro Vch recalled by Medline IndustriesMedline IndustriesOtherNationwide
DeviceCLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Fixed Pin Connector recalledOlympus Corporation of the AmericasOtherNationwide
DeviceCLASS IIIngenia 3.0T and Ingenia 3.0T CX recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIPresource Convenience Kits: KIT, Usgpiv recalled by Cardinal Health 200Cardinal Health 200Packaging DefectsNationwide
DeviceCLASS IIPowerLED 300 Concealed Lighting System recalled by Maquet SASMaquet SASOtherNationwide
DeviceCLASS IIEvolution upgrade 1.5T and Evolution upgrade 3.0T recalledPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIREF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 recalledVentec Life SystemsOtherNationwide
DeviceCLASS IIPresource Convenience Kits: KIT, PRE OP recalled by Cardinal Health 200Cardinal Health 200Packaging DefectsNationwide
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Coaxial Connector recalledOlympus Corporation of the AmericasOtherNationwide
DeviceCLASS IIHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalPackaging DefectsNationwide
DeviceCLASS IIPRO+ 40" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
DeviceCLASS IIAchieva XR recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIREF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalledDeRoyal IndustriesTemperature AbuseNationwide
DeviceCLASS IHalyard IV Start Kit Non-sterile recalled by Avid MedicalAvid MedicalOtherNationwide
DeviceCLASS IIREF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalledVentec Life SystemsOtherNationwide
DeviceCLASS IIIngenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T recalledPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Coaxial Connector recalledOlympus Corporation of the AmericasOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.