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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-12-10Z-0806-2026Class IIFood Intolerance Test LargeGET TESTED INTERNATIONAL AB
2025-12-10Z-0807-2026Class IIFood Intolerance Test MediumGET TESTED INTERNATIONAL AB
2025-12-10Z-0808-2026Class IIFood Intolerance Test SmallGET TESTED INTERNATIONAL AB
2025-12-10Z-0809-2026Class IIHeavy Metals TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0810-2026Class IIIodine TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0811-2026Class IIIron Deficiency TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0812-2026Class IIMelatonin TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0813-2026Class IIPet Allergy TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0814-2026Class IIPollen Allergy TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0815-2026Class IISerotonin TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0816-2026Class II2 in 1 Trichomonas / Gardnerella TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0817-2026Class II3 in 1 STI TestGET TESTED INTERNATIONAL AB
2025-12-10Z-0818-2026Class II8 in 1 STI Test KitGET TESTED INTERNATIONAL AB
2025-12-10Z-0847-2026Class IIWelch Allyn INF BAGBaxter Healthcare Corporation
2025-12-10Z-0848-2026Class IIIvenix Infusion SystemFresenius Kabi USA, LLC
2025-12-10Z-0849-2026Class IIIntelliVue MP2Philips North America Llc
2025-12-10Z-0850-2026Class IIIntelliVue MP5Philips North America Llc
2025-12-10Z-0851-2026Class IIIntelliVue MP20Philips North America Llc
2025-12-10Z-0852-2026Class IIIntelliVue MP30Philips North America Llc
2025-12-10Z-0853-2026Class IIIntelliVue MP40Philips North America Llc
2025-12-10Z-0854-2026Class IIIntelliVue MP50Philips North America Llc
2025-12-10Z-0855-2026Class IIIntelliVue MP60Philips North America Llc
2025-12-10Z-0856-2026Class IIIntelliVue MP70Philips North America Llc
2025-12-10Z-0857-2026Class IIIntelliVue MP80Philips North America Llc
2025-12-10Z-0858-2026Class IIIntelliVue MP90Philips North America Llc
2025-12-10Z-0859-2026Class IIIntelliVue Multi Measurement Server X2Philips North America Llc
2025-12-10Z-0860-2026Class IIIntelliVue Multi-Measurement Module X3Philips North America Llc
2025-12-10Z-0861-2026Class IIIntelliVue Patient Monitor MX100Philips North America Llc
2025-12-10Z-0862-2026Class IIIntelliVue Patient Monitor MX400Philips North America Llc
2025-12-10Z-0863-2026Class IIIntelliVue Patient Monitor MX450Philips North America Llc
2025-12-10Z-0864-2026Class IIIntelliVue Patient Monitor MX500Philips North America Llc
2025-12-10Z-0865-2026Class IIIntelliVue Patient Monitor MX550Philips North America Llc
2025-12-10Z-0866-2026Class IIIntelliVue Patient Monitor MX600Philips North America Llc
2025-12-10Z-0867-2026Class IIIntelliVue Patient Monitor MX700Philips North America Llc
2025-12-10Z-0868-2026Class IIIntelliVue Patient Monitor MX750Philips North America Llc
2025-12-10Z-0869-2026Class IIIntelliVue Patient Monitor MX800Philips North America Llc
2025-12-10Z-0870-2026Class IIIntelliVue Patient Monitor MX850Philips North America Llc
2025-12-10Z-0871-2026Class IIPhantom Fibula NailParagon 28, Inc.
2025-12-10Z-0872-2026Class IIOlympus OER-EliteAizu Olympus Co., Ltd.
2025-12-10Z-0873-2026Class IIOlympus OER-ProAizu Olympus Co., Ltd.
2025-12-10Z-0874-2026Class IIOlympus OER-MiniAizu Olympus Co., Ltd.
2025-12-10Z-0876-2026Class IIKWIK-STIKMicrobiologics Inc
2025-12-10Z-0877-2026Class IIMAMMOMAT RevelationSiemens Medical Solutions USA, Inc
2025-12-10Z-0878-2026Class IIMAMMOMAT InspirationSiemens Medical Solutions USA, Inc
2025-12-10Z-0879-2026Class IIMAMMOMAT FusionSiemens Medical Solutions USA, Inc
2025-12-10Z-0880-2026Class IIHemochron Activated Clotting Time Low-Range Test CuvetteAccriva Diagnostics, Inc.
2025-12-10Z-0881-2026Class IIIncisive CTPhilips North America Llc
2025-12-10Z-0882-2026Class IICT 5300Philips North America Llc
2025-12-10Z-0883-2026Class IILumify Diagnostic Ultrasound System models : 795005Philips Ultrasound, LLC
2025-12-10Z-0884-2026Class IIReagent Kits/ containing flow cellsIllumina, Inc.
2025-12-03Z-0531-2026Class ISJM Pericardial PatchGlycar SA Pty., Ltd.
2025-12-03Z-0532-2026Class ISJM Pericardial PatchGlycar SA Pty., Ltd.
2025-12-03Z-0570-2026Class IBrand Name: Single Use Ligating Device Product Name: Olympus…Olympus Corporation of the Americas
2025-12-03Z-0577-2026Class IIFoundationOne CDxFoundation Medicine, Inc.
2025-12-03Z-0578-2026Class IIFoundationOne Liquid CDxFoundation Medicine, Inc.
2025-12-03Z-0579-2026Class IIBrand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus…Olympus Corporation of the Americas
2025-12-03Z-0580-2026Class IICatalyft PL & PL40 Expandable Interbody System labeled as follows…Medtronic Sofamor Danek USA Inc
2025-12-03Z-0581-2026Class IICONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20KAlcon Research LLC
2025-12-03Z-0582-2026Class IIEmdogainStraumann USA LLC
2025-12-03Z-0583-2026Class IIDermaSensorDERMASENSOR INC
2025-12-03Z-0584-2026Class IIThe LeadCare¿ II Blood Lead Test System relies on electrochemistry…Magellan Diagnostics, Inc.
2025-12-03Z-0585-2026Class II1Remel, Inc
2025-12-03Z-0587-2026Class IIQuantum Intersegmental TablePivotal Health Solutions, Inc.
2025-12-03Z-0588-2026Class IIQuantum Intersegmental TablePivotal Health Solutions, Inc.
2025-12-03Z-0589-2026Class IIOption"ELITE Vena Cava Filter System REF 352506070E UDI-DI code:…Argon Medical Devices, Inc
2025-12-03Z-0594-2026Class IICareLink ClinicMedtronic MiniMed, Inc.
2025-12-03Z-0595-2026Class IIFlexLabInpeco S.A.
2025-12-03Z-0596-2026Class IIFlexLabInpeco S.A.
2025-12-03Z-0598-2026Class IIBrand Name: Galaxy System Product Name: Galaxy System Model/Catalog…Noah Medical Corporation
2025-12-03Z-0599-2026Class IINICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHPStryker Corporation
2025-12-03Z-0600-2026Class IINICO Myriad Illumination Pack Product NoStryker Corporation
2025-12-03Z-0601-2026Class IINICO BrainPathStryker Corporation
2025-12-03Z-0602-2026Class IIBioFire Respiratory Panel 2BioFire Diagnostics, LLC
2025-12-03Z-0603-2026Class IIADDitIV utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0604-2026Class IIADDitIV utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0605-2026Class IIADDitIV utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0606-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0607-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0608-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0609-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0610-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0611-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0612-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0613-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0614-2026Class IIAnesthesia IV Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0615-2026Class IIBB Braun Medical Inc
2025-12-03Z-0616-2026Class IIBlood Administration Set utilized in gravity IV administration sets…B Braun Medical Inc
2025-12-03Z-0617-2026Class IIBlood Administration Set utilized in gravity IV administration sets…B Braun Medical Inc
2025-12-03Z-0618-2026Class IIBlood Administration Set utilized in gravity IV administration sets…B Braun Medical Inc
2025-12-03Z-0619-2026Class IIBlood Administration Set utilized in gravity IV administration sets…B Braun Medical Inc
2025-12-03Z-0620-2026Class IIBlood Administration Set utilized in gravity IV administration sets…B Braun Medical Inc
2025-12-03Z-0621-2026Class IIBurette Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0622-2026Class IIBurette Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0623-2026Class IICARESAFE utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0624-2026Class IICaresite utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0625-2026Class IICaresite utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0626-2026Class IICaresite utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0627-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0628-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0629-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0630-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0631-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0632-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0633-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0634-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0635-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0636-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0637-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0638-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0639-2026Class IIExtension Set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0640-2026Class IIInfusomat utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0641-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0642-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0643-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0644-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0645-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0646-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0647-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0648-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0649-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0650-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0651-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0652-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0653-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0654-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0655-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0656-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0657-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0658-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0659-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0660-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0661-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0662-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0663-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0664-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0665-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0666-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0667-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0668-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0669-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0670-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0671-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0672-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0673-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0674-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0675-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0676-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0677-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0678-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0679-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0680-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0681-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0682-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0683-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0684-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0685-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0686-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0687-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0688-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0689-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0690-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0691-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0692-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0693-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0694-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0695-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0696-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0697-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0698-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0699-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0700-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0701-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0702-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0703-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0704-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0705-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0706-2026Class IIOutlook set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0707-2026Class IIOutlook set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0708-2026Class IIOutlook set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0709-2026Class IIOutlook set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0710-2026Class IIRATE FLOW set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0711-2026Class IISafeDAY set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0712-2026Class IISafeDAY set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0713-2026Class IISAFELINE set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0714-2026Class IIULTRASITE set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0715-2026Class IIVista set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0716-2026Class IIOutlook set utilized in gravity IV administration sets and pump…B Braun Medical Inc
2025-12-03Z-0717-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0718-2026Class IIIV Administration Set utilized in gravity IV administration sets and…B Braun Medical Inc
2025-12-03Z-0719-2026Class IIPhilips Azurion 7M20 systems with FlexArm ceiling-mounted systemPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-12-03Z-0720-2026Class IISevofluraneMindray DS USA, Inc. dba Mindray North America
2025-12-03Z-0721-2026Class IIIsofluraneMindray DS USA, Inc. dba Mindray North America
2025-12-03Z-0722-2026Class IICold Form Wrap: BackDJO, LLC
2025-12-03Z-0723-2026Class IIIntelePACSINTELERAD MEDICAL SYSTEMS INCORPORATED
2025-12-03Z-0724-2026Class IIXpert MTB/RIFCepheid
2025-11-26Z-0430-2026Class IBD Alaris infusion Pump Module 8100CareFusion 303, Inc.
2025-11-26Z-0488-2026Class ITMJ Bilateral Implant REF: CHG020 Sterile EOTMJ Solutions Inc
2025-11-26Z-0503-2026Class IIMOSAIQ Oncology Information System Software Builds 3ELEKTA SOLUTIONS AB
2025-11-26Z-0504-2026Class IIBD Luer Tip CapsBecton Dickinson & Company
2025-11-26Z-0505-2026Class IIBrand Name: HeartMate Product Name: HeartMate 3 Left Ventricular…Thoratec LLC

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