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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-01-15Z-0712-2025Class IVasoview Hemopro 2Maquet Cardiovascular, LLC
2025-01-15Z-0763-2025Class IIvenix Infusion SystemFresenius Kabi USA, LLC
2025-01-15Z-0795-2025Class IJMC5A Ni/TruAire-5 Oxygen ConcentratorJIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
2025-01-15Z-0801-2025Class IIDialyzer Optiflux 160NReFresenius Medical Care Holdings, Inc.
2025-01-15Z-0802-2025Class IIVACUETTE SAFELINKGreiner Bio-One GmbH
2025-01-15Z-0803-2025Class IIAccess Intact PTH assayBeckman Coulter, Inc.
2025-01-15Z-0804-2025Class IISmaxel Fractional CO2 LaserIDS LTD
2025-01-15Z-0805-2025Class IIIThe FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen Inc
2025-01-15Z-0806-2025Class IIEnVisio Patient Pad Transition CushionElucent Medical Inc
2025-01-15Z-0807-2025Class II100V NEPTUNE 3 ROVER JAPANESEStryker Corporation
2025-01-15Z-0808-2025Class IIAerin Medical VivAer StylusAerin Medical, Inc.
2025-01-15Z-0809-2025Class IIXhibit Telemetry ReceiverSpacelabs Healthcare, Inc.
2025-01-15Z-0810-2025Class IIXhibit Telemetry Receiver with SoftwareSpacelabs Healthcare, Inc.
2025-01-15Z-0811-2025Class IIGE Healthcare Optima XR200amxGE Medical Systems, LLC
2025-01-15Z-0812-2025Class IIGE Healthcare Optima XR220amxGE Medical Systems, LLC
2025-01-15Z-0813-2025Class IIGE Healthcare Optima XR240amxGE Medical Systems, LLC
2025-01-15Z-0814-2025Class IITec 6 Plus Anesthesia VaporizerGE Medical Systems, LLC
2025-01-15Z-0815-2025Class IITec 820 ISO Anesthesia VaporizerGE Medical Systems, LLC
2025-01-15Z-0816-2025Class IITec 820 SEV Anesthesia VaporizerGE Medical Systems, LLC
2025-01-15Z-0817-2025Class IITec 850 ISO Anesthesia VaporizerGE Medical Systems, LLC
2025-01-15Z-0818-2025Class IITec 850 SEV Anesthesia VaporizerGE Medical Systems, LLC
2025-01-15Z-0819-2025Class IIAMT Mini Enteral Extension SetApplied Medical Technology Inc
2025-01-15Z-0820-2025Class IICitric CompleteNipro Renal Soultions USA, Corporation
2025-01-15Z-0828-2025Class IIBrand Name: 3B Medical3B Medical, Inc.
2025-01-08Z-0770-2025Class IIAURYON LASER SYSTEM 100-120 VACAngiodynamics, Inc.
2025-01-08Z-0771-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable…Medtronic Neuromodulation
2025-01-08Z-0772-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable…Medtronic Neuromodulation
2025-01-08Z-0773-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable…Medtronic Neuromodulation
2025-01-08Z-0774-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable…Medtronic Neuromodulation
2025-01-08Z-0775-2025Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2025-01-08Z-0776-2025Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2025-01-08Z-0777-2025Class IIMedline custom medical procedure kits labeled as: 1) CATH LAB PACK-LFMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0778-2025Class IIMedline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LFMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0779-2025Class IIMedline custom medical procedure kits labeled as: 1) VP SHUNT CDSMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0780-2025Class IIMedline custom medical procedure kits labeled as: 1) UMC DRMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0781-2025Class IIMedline custom medical procedure kits labeled as: 1) NASAL PACKMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0782-2025Class IISee DocManMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0783-2025Class IIMedline custom medical procedure kits labeled as: 1) FREE FLAP BASIC…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0784-2025Class IIMedline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0785-2025Class IIMedline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LFMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0786-2025Class IIMedline custom medical procedure kits labeled as: 1) MEM…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0787-2025Class IIMedline custom medical procedure kits labeled as: 1) NEURO BASIN…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0788-2025Class IISee DocManMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0789-2025Class IIMedline custom medical procedure kits labeled as: 1) MICRODISECTOMY…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0790-2025Class IISee DocManMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0791-2025Class IIMedline custom medical procedure kits labeled as: DEEP BRAIN…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0792-2025Class IIMedline custom medical procedure kits labeled as: 1) ENSEMBLE…MEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0793-2025Class IIMedline custom medical procedure kits labeled as: 1) CERVICAL PACK-LFMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0794-2025Class IIMedline custom medical procedure kits labeled as: 1) CRANIMEDLINE INDUSTRIES, LP - Northfield
2025-01-08Z-0796-2025Class IISUC-4300SMed Michigan Holding Llc
2025-01-08Z-0797-2025Class II3M Unitek Transbond Plus Self-Etching Primer REF 712-0903M Unitek Corporation
2025-01-08Z-0798-2025Class IIIvalon Eye Wick 20cm- Intended to be used for the removal and…Carwild Corporation
2025-01-08Z-0799-2025Class IIIvalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During…Carwild Corporation
2025-01-08Z-0800-2025Class IIIvalon Anatomical Nasal Packing with Airway Tube and StringCarwild Corporation
2025-01-01Z-0681-2025Class IStatStrip Glucose Hospital Meter SystemNova Biomedical Corporation
2025-01-01Z-0682-2025Class IStatStrip Glucose Ketone Hospital Meter SystemNova Biomedical Corporation
2025-01-01Z-0683-2025Class IStatStrip Glucose KetoneNova Biomedical Corporation
2025-01-01Z-0694-2025Class IIPanther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc.
2025-01-01Z-0708-2025Class IMonitoring Service ApplicationBraemar Manufacturing, LLC
2025-01-01Z-0717-2025Class IIMAJOR NEURO PACK-LF Convenience kitMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0718-2025Class IIFESS-MB PACK-LF Convenience kitMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0719-2025Class IIDIEP FLAP Convenience kitMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0720-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0721-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0722-2025Class IISEPTOPLASTY PACK Convenient kitMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0723-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0724-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0725-2025Class IIKITMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0726-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0727-2025Class IIAccess hsTnI ReagentBeckman Coulter, Inc.
2025-01-01Z-0728-2025Class IIO&M Halyard Procedure Mask with SO SOFT* EarloopsO&M HALYARD, INC.
2025-01-01Z-0729-2025Class IIO&M Halyard SOFT TOUCH II Surgical MaskO&M HALYARD, INC.
2025-01-01Z-0730-2025Class II20/30 INDEFLATORAbbott Vascular Inc
2025-01-01Z-0731-2025Class II20/30 Priority Pack Accessory Kit/Abbott Vascular Inc
2025-01-01Z-0732-2025Class II20/30 Priority Pack Accessory Kit w/CopilotAbbott Vascular Inc
2025-01-01Z-0733-2025Class II20/30 Priority Pack Kit/Abbott Vascular Inc
2025-01-01Z-0734-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0735-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0736-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0737-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0738-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0739-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0740-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0741-2025Class IIepoc NXS HostSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0742-2025Class IIGalaxy SystemNoah Medical
2025-01-01Z-0743-2025Class IIClarity Precision Grip Attachments3M Company - Health Care Business
2025-01-01Z-0744-2025Class IITEMA ElbowLimacorporate S.p.A
2025-01-01Z-0745-2025Class IIFACSLyric 2L4C Instrument USBecton, Dickinson and Company, BD Bio Sciences
2025-01-01Z-0746-2025Class IIDevice Description: FACSLyric 2L6C Instrument USBecton, Dickinson and Company, BD Bio Sciences
2025-01-01Z-0747-2025Class IIFACSLyric 3L8C Instrument US-IVDBecton, Dickinson and Company, BD Bio Sciences
2025-01-01Z-0748-2025Class IIFACSLyric 3L10C Instrument US-IVDBecton, Dickinson and Company, BD Bio Sciences
2025-01-01Z-0749-2025Class IIFACSLyric 3L12C Instrument RUOBecton, Dickinson and Company, BD Bio Sciences
2025-01-01Z-0750-2025Class IIBYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE…Straight Smile, LLC
2025-01-01Z-0751-2025Class IIBrand Name: Daytona Small Stature Product Name: CoCr LockingCap 4SEASPINE ORTHOPEDICS CORPORATION
2025-01-01Z-0752-2025Class IIBrand Name: Daytona Small Stature Product Name: Ti Locking Cap 4SEASPINE ORTHOPEDICS CORPORATION
2025-01-01Z-0753-2025Class IIThe Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer…Abbott Medical
2025-01-01Z-0754-2025Class IISTERILE STRT KELLY HEMOSTATMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0755-2025Class IIOMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0756-2025Class IIST OR MAYO HEGAR NEEDLEHOLDER 6"MEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0757-2025Class IISTERILE MAGILL FORCEPMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0758-2025Class IIST REPROCESSED BRUNS CURETTE #00MEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0759-2025Class IIST IUD REMOVAL HOOK 10"MEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0760-2025Class IIRUMMELLMEDLINE INDUSTRIES, LP - Northfield
2025-01-01Z-0761-2025Class IIEMPOWR 3D Knee Tibial InsertEncore Medical, LP
2025-01-01Z-0762-2025Class IIMISHA Knee System Implant SmallMoximed, Inc.
2025-01-01Z-0766-2025Class IIEMPOWR 3D Knee Tibial InsertEncore Medical, LP
2025-01-01Z-0767-2025Class IIMagnesium Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.
2025-01-01Z-0769-2025Class IILINK MP Reconstruction System Neck SegmentWaldemar Link GmbH & Co. KG (Mfg Site)

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