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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-12-31Z-0923-2026Class IIBrand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA…AGFA Healthcare Corp.
2025-12-31Z-0933-2026Class IDraeger Vapor 2000Draeger, Inc.
2025-12-31Z-0934-2026Class IDraeger Vapor 3000Draeger, Inc.
2025-12-31Z-0939-2026Class IBrand Name: Alcon LaboratoriesAlcon Research LLC
2025-12-31Z-0962-2026Class IIBD Pyxis MedStation ESCareFusion 303, Inc.
2025-12-31Z-0963-2026Class IIThe Stryker CranialMask Tracker is a single-use device consisting of…Howmedica Osteonics Corp.
2025-12-31Z-0964-2026Class IIda Vinci 5Intuitive Surgical, Inc.
2025-12-31Z-0965-2026Class IILifeShield Drug Library ManagementICU Medical, Inc.
2025-12-31Z-0966-2026Class IILifeShield Drug Library ManagementICU Medical, Inc.
2025-12-31Z-0967-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0968-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0969-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0970-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0971-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0972-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0973-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0974-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0975-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0976-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0977-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0978-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0979-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0980-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0981-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0982-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0983-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name:…Zimmer, Inc.
2025-12-31Z-0984-2026Class IIKWIK-STIK 2-PackMicrobiologics Inc
2025-12-31Z-0985-2026Class IIKWIK-STIK 6-PackMicrobiologics Inc
2025-12-31Z-0986-2026Class IILYFO DISKMicrobiologics Inc
2025-12-31Z-0987-2026Class IIBrand Name: Diasol Product Name: 100225-10-DEX100Diasol, Inc
2025-12-31Z-0988-2026Class IIBrand Name: Diasol Product Name: 100125-10-DEX100Diasol, Inc
2025-12-31Z-0989-2026Class IIBrand Name: Diasol Product Name: 100220-10-DEX100Diasol, Inc
2025-12-31Z-0990-2026Class IIBrand Name: Diasol Product Name: 100230-10-DEX100Diasol, Inc
2025-12-31Z-0991-2026Class IIBrand Name: Diasol Product Name: 100325-10-DEX100Diasol, Inc
2025-12-31Z-0992-2026Class IIBrand Name: Diasol Product Name: 100425-10-DEX100Diasol, Inc
2025-12-31Z-0993-2026Class IIFlexor Check-Flo Introducers and SetsCook Incorporated
2025-12-31Z-0994-2026Class IIRing Transjugular Intrahepatic Access SetsCook Incorporated
2025-12-31Z-0995-2026Class IIR¿sch-Uchida Transjugular Liver Access SetsCook Incorporated
2025-12-31Z-0996-2026Class IIRestore Clinician Programmer ApplicationMedtronic Neuromodulation
2025-12-31Z-0997-2026Class IIBECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37…Beckman Coulter Ireland, Inc.
2025-12-24Z-0885-2026Class IIvenix Infusion SystemFresenius Kabi USA, LLC
2025-12-24Z-0913-2026Class IGE Healthcare Carestation anesthesia systemGE Medical Systems China Co., Ltd.
2025-12-24Z-0914-2026Class IGE Healthcare Carestation anesthesia systemGE Medical Systems China Co., Ltd.
2025-12-24Z-0915-2026Class IGE Healthcare Carestation anesthesia system Power Management BoardGE Medical Systems China Co., Ltd.
2025-12-24Z-0920-2026Class IIHardware configuration of the BeneVision Central Monitoring SystemMindray DS USA, Inc. dba Mindray North America
2025-12-24Z-0921-2026Class IISCISSORSMedline Industries, LP
2025-12-24Z-0922-2026Class IIFORCEPMedline Industries, LP
2025-12-24Z-0924-2026Class IIZimmer Air DermatomeZimmer Surgical Inc
2025-12-24Z-0925-2026Class IIZimmer Dermatome ANZimmer Surgical Inc
2025-12-24Z-0926-2026Class IIHalyardAVID Medical, Inc.
2025-12-24Z-0927-2026Class IIHalyardAVID Medical, Inc.
2025-12-24Z-0928-2026Class IIHalyardAVID Medical, Inc.
2025-12-24Z-0929-2026Class IIHalyardAVID Medical, Inc.
2025-12-24Z-0930-2026Class IIHalyardAVID Medical, Inc.
2025-12-24Z-0931-2026Class IIICardiosave HybridDatascope Corp.
2025-12-24Z-0932-2026Class IIICardiosave RescueDatascope Corp.
2025-12-24Z-0935-2026Class IIGE HealthCare ViewPoint 6GE Healthcare GmbH
2025-12-24Z-0936-2026Class II5008X CAREsystem +CLiC +CDXFresenius Medical Care Holdings, Inc.
2025-12-24Z-0937-2026Class IIOrthofix NorthStar OCT Navigation Surgical Technique GuideSEASPINE ORTHOPEDICS CORPORATION
2025-12-24Z-0938-2026Class IIIHemosIL SynthAFaxInstrumentation Laboratory
2025-12-24Z-0940-2026Class IIMADSEN ACCUSCREEN TEOAE/DPOAE/ABR ProbePATH
2025-12-24Z-0941-2026Class IIIntelerad InteleShare softwareDICOM Grid, Inc.
2025-12-24Z-0942-2026Class II1ml of DTT in liquid phaseCopan Italia
2025-12-24Z-0943-2026Class II1ml of DTT in liquid phaseCopan Italia
2025-12-24Z-0944-2026Class IIBrand Name: AART Silicone Carving Implant Product Name: Silicone…DSAART LLC
2025-12-24Z-0945-2026Class IIBrand Name: AART Gluteal Implant Product Name: Gluteal Implant…DSAART LLC
2025-12-24Z-0946-2026Class IIBrand Name: AART Chin Implant Product Name: Chin Implant…DSAART LLC
2025-12-24Z-0947-2026Class IIBrand Name: AART Malar Implant Product Name: Malar Implant…DSAART LLC
2025-12-24Z-0948-2026Class IIBrand Name: AART Pectoral Implant Product Name: Pectoral Implant…DSAART LLC
2025-12-24Z-0949-2026Class IIBrand Name: AART Calf Implant Product Name: Calf Implant…DSAART LLC
2025-12-24Z-0950-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter…Rocket Medical Plc
2025-12-24Z-0951-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with…Rocket Medical Plc
2025-12-24Z-0952-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter…Rocket Medical Plc
2025-12-24Z-0953-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with…Rocket Medical Plc
2025-12-24Z-0954-2026Class IIBrand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter…Rocket Medical Plc
2025-12-24Z-0955-2026Class IIBrand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter…Rocket Medical Plc
2025-12-24Z-0956-2026Class IIMyosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF…Myofunctional Research Company USA
2025-12-24Z-0957-2026Class IIBIOSURE HA SCREWSmith & Nephew, Inc.
2025-12-24Z-0958-2026Class IIInPen AppMedtronic MiniMed, Inc.
2025-12-24Z-0959-2026Class IIBrand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Cepheid
2025-12-24Z-0960-2026Class IIBrand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10Cepheid
2025-12-24Z-0961-2026Class IIAlinity ci-series System Control ModuleAbbott Laboratories
2025-12-17Z-0590-2026Class IErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for…Draeger, Inc.
2025-12-17Z-0591-2026Class IErgoStar CM 45Draeger, Inc.
2025-12-17Z-0592-2026Class IErgoStar CM 55Draeger, Inc.
2025-12-17Z-0593-2026Class IErgoStar CM 60Draeger, Inc.
2025-12-17Z-0597-2026Class IIAzurion R3Philips North America
2025-12-17Z-0875-2026Class IISenographe PristinaGE Medical Systems, LLC
2025-12-17Z-0886-2026Class IIMEDLINE PERFUSION SYRINGEMedline Industries, LP
2025-12-17Z-0887-2026Class IISafe-T-Centesis 6 Fr Catheter Drainage TrayBard Peripheral Vascular Inc
2025-12-17Z-0889-2026Class IIAccess 2 Reaction VesselsBeckman Coulter, Inc.
2025-12-17Z-0890-2026Class IIEndo Model Knee Fusion Nail SKWaldemar Link GmbH & Co. KG (Mfg Site)
2025-12-17Z-0891-2026Class IIIBrand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX"…Orthofix U.S. LLC
2025-12-17Z-0892-2026Class IIIBrand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer…Orthofix U.S. LLC
2025-12-17Z-0893-2026Class IIIBrand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC…Orthofix U.S. LLC
2025-12-17Z-0894-2026Class IIIBrand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI…Orthofix U.S. LLC
2025-12-17Z-0895-2026Class IIIBrand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer…Orthofix U.S. LLC
2025-12-17Z-0896-2026Class IIIBrand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX"…Orthofix U.S. LLC
2025-12-17Z-0897-2026Class IIChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus…Cardinal Health 200, LLC
2025-12-17Z-0898-2026Class IICURAD Germ-Shield Touch-Free Fabric BandagesMedline Industries, LP
2025-12-17Z-0899-2026Class IICurad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3"Medline Industries, LP
2025-12-17Z-0900-2026Class IIQuick Strip Plastic Sterile Adhesive BandagesMedline Industries, LP
2025-12-17Z-0901-2026Class IIQuick Strip Plastic Sterile Adhesive BandagesMedline Industries, LP
2025-12-17Z-0902-2026Class IIFur Friends Plastic Sterile Adhesive BandagesMedline Industries, LP
2025-12-17Z-0903-2026Class IIQuick Strip Fabric Sterile Adhesive BandagesMedline Industries, LP
2025-12-17Z-0904-2026Class IIQuick Strip Fabric Sterile Adhesive BandagesMedline Industries, LP
2025-12-17Z-0905-2026Class IIBard InLay Optima Size: 6 FrC.R. Bard Inc
2025-12-17Z-0906-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 4C.R. Bard Inc
2025-12-17Z-0907-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 6 FrC.R. Bard Inc
2025-12-17Z-0908-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 8 FrC.R. Bard Inc
2025-12-17Z-0909-2026Class IIAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product…Steris Corporation
2025-12-17Z-0910-2026Class IIAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product…Steris Corporation
2025-12-17Z-0911-2026Class IIDEXLOCK Achilles Repair Implant KitsMedline Industries, LP
2025-12-17Z-0912-2026Class IIHemodialysis SystemNipro Medical Corporation
2025-12-17Z-0916-2026Class IICardiosave HybridDatascope Corp.
2025-12-17Z-0917-2026Class IICardiosave RescueDatascope Corp.
2025-12-17Z-0918-2026Class IIStryker MV3 bariatric bedStryker Medical Division of Stryker Corporation
2025-12-17Z-0919-2026Class IIStryker Arise 1000EX mattressStryker Medical Division of Stryker Corporation
2025-12-10Z-0586-2026Class IIVENIX INFUSION SYSTEMFresenius Kabi USA, LLC
2025-12-10Z-0725-2026Class IIInSure ONE Fecal Immunochemical TestEnterix, Inc.
2025-12-10Z-0726-2026Class IIAurora EV-ICD and Clinical EV-ICDMedtronic, Inc.
2025-12-10Z-0727-2026Class IIAlcoholGET TESTED INTERNATIONAL AB
2025-12-10Z-0728-2026Class IIBlood Type TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0729-2026Class IICandida TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0730-2026Class IIChlamydia TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0731-2026Class IID-Dimer TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0732-2026Class IIDiabetes HbA1c TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0733-2026Class IIIllegally MarketedGET TESTED INTERNATIONAL AB
2025-12-10Z-0734-2026Class IIDrug Test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0735-2026Class IIEpstein-Barr VirusGET TESTED INTERNATIONAL AB
2025-12-10Z-0736-2026Class IIFecal Occult Blood TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0737-2026Class IIFemale Fertility TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0738-2026Class IIGonorrhea testGET TESTED INTERNATIONAL AB
2025-12-10Z-0739-2026Class IIH pyloriGET TESTED INTERNATIONAL AB
2025-12-10Z-0740-2026Class IIHerpesGET TESTED INTERNATIONAL AB
2025-12-10Z-0741-2026Class IIHPV Antigen TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0742-2026Class IIIron Deficiency TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0743-2026Class IILyme TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0744-2026Class IIMenopauseGET TESTED INTERNATIONAL AB
2025-12-10Z-0745-2026Class IIMPOX TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0746-2026Class IIMycoplasma testGET TESTED INTERNATIONAL AB
2025-12-10Z-0747-2026Class IIOvulation TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0748-2026Class IIParasite TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0749-2026Class IIPregnancy TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0750-2026Class IISperm TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0751-2026Class IISyphilis TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0752-2026Class IIThyroid TSH TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0753-2026Class IITrichomonas Vaginalis testGET TESTED INTERNATIONAL AB
2025-12-10Z-0754-2026Class IIUrinary Tract Infection TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0755-2026Class IIVaginal PH TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0756-2026Class IIVitamin D-TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0757-2026Class IISperm TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0758-2026Class IIEnvironmental Pollutants Profile TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0759-2026Class IIFood Allergy Panel TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0760-2026Class IIFood Sensitivity Test LargeGET TESTED INTERNATIONAL AB
2025-12-10Z-0761-2026Class IIFood Sensitivity Test MediumGET TESTED INTERNATIONAL AB
2025-12-10Z-0762-2026Class IIFood Sensitivity Test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0763-2026Class IIGI Microbiome Profile SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0764-2026Class IIGI Microbiome Profile XLGET TESTED INTERNATIONAL AB
2025-12-10Z-0765-2026Class IIMycotoxin Panel TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0766-2026Class IINAD Profile TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0767-2026Class IIOrganic Acids Profile Test LargeGET TESTED INTERNATIONAL AB
2025-12-10Z-0768-2026Class IIVitamin D2 and D3 TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0769-2026Class IIAllergy Test IgEGET TESTED INTERNATIONAL AB
2025-12-10Z-0770-2026Class IIContinuous Glucose MonitorGET TESTED INTERNATIONAL AB
2025-12-10Z-0771-2026Class IICholesterol TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0772-2026Class IIAdrenal TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0773-2026Class IIAkkermansia TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0774-2026Class IIBiological Age & Longevity TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0775-2026Class IICandida TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0776-2026Class IIDHEA TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0777-2026Class IIFructose Intolerance TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0778-2026Class IIGut Microbiome Test LargeGET TESTED INTERNATIONAL AB
2025-12-10Z-0779-2026Class IIGut Microbiome Test MediumGET TESTED INTERNATIONAL AB
2025-12-10Z-0780-2026Class IIGut Microbiome Test MegaGET TESTED INTERNATIONAL AB
2025-12-10Z-0781-2026Class IIGut Microbiome Test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0782-2026Class IIGut Microbiome Test XLGET TESTED INTERNATIONAL AB
2025-12-10Z-0783-2026Class IIHair Mineral AnalysisGET TESTED INTERNATIONAL AB
2025-12-10Z-0784-2026Class IIIBS TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0785-2026Class IIIntestinal Worms TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0786-2026Class IILactose Intolerance TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0787-2026Class IILeaky Gut TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0788-2026Class IIMen s Hormone TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0789-2026Class IINeurotransmitters BasicGET TESTED INTERNATIONAL AB
2025-12-10Z-0790-2026Class IINeurotransmitters PlusGET TESTED INTERNATIONAL AB
2025-12-10Z-0791-2026Class IINeurotransmitters XLGET TESTED INTERNATIONAL AB
2025-12-10Z-0792-2026Class IIOrganic acids TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0793-2026Class IIParasite TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0794-2026Class IIPeptic Ulcer TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0795-2026Class IIPSA TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0796-2026Class IISIBO TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0797-2026Class IISorbitol Intolerance TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0798-2026Class IIWomen s Hormone TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0799-2026Class IIDiabetes TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0800-2026Class IIKidney TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0801-2026Class IILiver TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0802-2026Class IIAllergy & Food Intolerance TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0803-2026Class IIAllergy test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0804-2026Class IIAllergy test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0805-2026Class IIEstrogen & Progesterone TestGET TESTED INTERNATIONAL AB

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