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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-08-06Z-2161-2025Class ISafeStar 60A Plus FilterDraeger, Inc.
2025-08-06Z-2164-2025Class IAutomated Impella ControllerAbiomed, Inc.
2025-08-06Z-2167-2025Class IBreathing circuit setHamilton Medical AG
2025-08-06Z-2172-2025Class IIThe Drill Stop Kit is the version of the Mini Sterilizable Tray that…Implant Direct Sybron Manufacturing LLC
2025-08-06Z-2174-2025Class IIHeartSine SAM 350PHeartSine Technologies Ltd
2025-08-06Z-2175-2025Class IIInseego USB8 4G Dongle KitRemote Diagnostic Technologies Ltd.
2025-08-06Z-2177-2025Class IIDual Flat Panel MonitorSteris Corporation
2025-08-06Z-2178-2025Class IIDual Flat Panel MonitorSteris Corporation
2025-08-06Z-2188-2025Class IILIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometersMICROVENTION INC.
2025-08-06Z-2189-2025Class IIPhilips Allura R8PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-08-06Z-2190-2025Class IIBostonSight SCLERAL LensBoston Foundation For Sight
2025-08-06Z-2191-2025Class IIBostonSight PROSE LensBoston Foundation For Sight
2025-08-06Z-2192-2025Class IIPhasor DrillPhasor Health, LLC
2025-08-06Z-2193-2025Class IISprinter Cart/Sprinter Cart XL Infusion PoleMaquet Cardiopulmonary Gmbh
2025-08-06Z-2194-2025Class IILYFO-DISKMicrobiologics Inc
2025-08-06Z-2195-2025Class IILYFO-DISKMicrobiologics Inc
2025-08-06Z-2196-2025Class IIIontoPatch STATLTS Therapy Systems, LLC
2025-08-06Z-2197-2025Class IIIontoPatch 80LTS Therapy Systems, LLC
2025-08-06Z-2198-2025Class IIPrecision Sampling SetCapnia Inc
2025-08-06Z-2199-2025Class IISwabFlush Prefilled Syringe with ICU Medical SwabCapsMEDLINE INDUSTRIES, LP - Northfield
2025-08-06Z-2200-2025Class IIAchieva 3Philips North America
2025-08-06Z-2201-2025Class IIAchieva XRPhilips North America
2025-08-06Z-2202-2025Class IIEvolution Upgrade 1Philips North America
2025-08-06Z-2203-2025Class IIEvolution Upgrade 3Philips North America
2025-08-06Z-2204-2025Class IIIngenia 1Philips North America
2025-08-06Z-2205-2025Class IIIngenia 1Philips North America
2025-08-06Z-2206-2025Class IIIngenia 3Philips North America
2025-08-06Z-2207-2025Class IIIngenia 3Philips North America
2025-08-06Z-2208-2025Class IIIngenia Ambition S Model NumbersPhilips North America
2025-08-06Z-2209-2025Class IIIngenia Ambition X Model NumbersPhilips North America
2025-08-06Z-2210-2025Class IIIngenia Elition S Model NumbersPhilips North America
2025-08-06Z-2211-2025Class IIIngenia Elition X Model NumbersPhilips North America
2025-08-06Z-2212-2025Class IIIntera 3Philips North America
2025-08-06Z-2213-2025Class IIMR 5300 Model NumbersPhilips North America
2025-08-06Z-2214-2025Class IIMR 7700 Model NumbersPhilips North America
2025-08-06Z-2215-2025Class IISmartPath to dStream for 3Philips North America
2025-08-06Z-2216-2025Class IISmartPath to dStream for XR and 3Philips North America
2025-08-06Z-2217-2025Class IISmartPath to Ingenia Elition X Model NumbersPhilips North America
2025-08-06Z-2218-2025Class IIUpgrade to MR 7700 Model NumberPhilips North America
2025-08-06Z-2219-2025Class IIASPRIRE Cristalle Mammography SystemFUJIFILM Healthcare Americas Corporation
2025-08-06Z-2220-2025Class IIBrand Name: Celsior Cold Storage Solution Product Name: Celsior Cold…INSTITUT GEORGES LOPEZ
2025-08-06Z-2221-2025Class IIVolcano Visions Digital IVUS Catheter: PVVolcano Corp
2025-08-06Z-2222-2025Class IIBrand Name: Osteotec Product Name: Osteotec Silicone Finger Implant…Osteotec Limited
2025-08-06Z-2223-2025Class IIBlood AgarRemel, Inc
2025-08-06Z-2224-2025Class IIStrep Selective II AgarRemel, Inc
2025-08-06Z-2225-2025Class IIBlood/EMBRemel, Inc
2025-08-06Z-2226-2025Class IIBlood/MacConkey Biplate 100/PKRemel, Inc
2025-08-06Z-2230-2025Class IIRAPIDPoint 500 Systems Wash/Waste CartridgeSiemens Healthcare Diagnostics Inc
2025-08-06Z-2231-2025Class II3M Ranger Irrigation Fluid Warming Set3M Company
2025-08-06Z-2232-2025Class IILVP Primary Administration SetFresenius Kabi USA, LLC
2025-08-06Z-2233-2025Class IILVP Blood Products Administration Set Dual-InletFresenius Kabi USA, LLC
2025-08-06Z-2234-2025Class IILVP Primary Administration SetFresenius Kabi USA, LLC
2025-08-06Z-2235-2025Class IILVP Primary Administration SetFresenius Kabi USA, LLC
2025-07-30Z-2117-2025Class IIPortable X-ray systemDIGIMED CO., LTD
2025-07-30Z-2130-2025Class IISIGNA ArchitectGE Medical Systems, LLC
2025-07-30Z-2131-2025Class IISIGNA Architect AIRGE Medical Systems, LLC
2025-07-30Z-2132-2025Class IIDiscovery MR750w 3GE Medical Systems, LLC
2025-07-30Z-2133-2025Class IISIGNA PET/MRGE Medical Systems, LLC
2025-07-30Z-2134-2025Class IIAzurion 7 M20PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-07-30Z-2135-2025Class IIHSG Procedure TrayCooperSurgical, Inc.
2025-07-30Z-2136-2025Class IIEndosee System Convenience KitCooperSurgical, Inc.
2025-07-30Z-2137-2025Class IIEndosee System Convenience Kit with IV TubeCooperSurgical, Inc.
2025-07-30Z-2138-2025Class IINatus Brain Monitor Breakout BoxNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
2025-07-30Z-2139-2025Class IIBlue SiliconeOlympus Corporation of the Americas
2025-07-30Z-2140-2025Class IIGreen Silicone Seal for AccessoriesOlympus Corporation of the Americas
2025-07-30Z-2141-2025Class IIGlass Body For 194 Ellik EvacuatorOlympus Corporation of the Americas
2025-07-30Z-2142-2025Class IITubing for Male Connector 194Olympus Corporation of the Americas
2025-07-30Z-2143-2025Class IIEllik EvacuatorOlympus Corporation of the Americas
2025-07-30Z-2144-2025Class IIEllik Latex BulbOlympus Corporation of the Americas
2025-07-30Z-2145-2025Class IIEllik Evacuator AdapterOlympus Corporation of the Americas
2025-07-30Z-2146-2025Class IICone with Male TubingOlympus Corporation of the Americas
2025-07-30Z-2147-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR AcetabularEncore Medical, LP
2025-07-30Z-2148-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR AcetabularEncore Medical, LP
2025-07-30Z-2149-2025Class IIBodor's I series laser cutting machineJinan Bodor Cnc Machine Co Ltd
2025-07-30Z-2151-2025Class IICovidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100NCovidien
2025-07-30Z-2152-2025Class IIEstrone RIABeckman Coulter Inc.
2025-07-30Z-2153-2025Class IIMedline Convenience KitsMEDLINE INDUSTRIES, LP - Northfield
2025-07-30Z-2154-2025Class IIMedline Convenience KitsMEDLINE INDUSTRIES, LP - Northfield
2025-07-30Z-2155-2025Class IIMedline Convenience KitsMEDLINE INDUSTRIES, LP - Northfield
2025-07-30Z-2156-2025Class IIMedline Convenience KitsMEDLINE INDUSTRIES, LP - Northfield
2025-07-30Z-2157-2025Class IIBridge to Life EasiSlushBridge to Life Ltd
2025-07-30Z-2162-2025Class IIBD COR System SoftwareBecton Dickinson & Co.
2025-07-30Z-2163-2025Class IIACUVUE¿ OASYS MAX 1-Day MULTIFOCALJohnson & Johnson Vision Care, Inc.
2025-07-30Z-2165-2025Class IIBiofinity XR Toric Contact LensCooperVision, Inc.
2025-07-30Z-2166-2025Class IIBiofinity Toric Multifocal Contact LensCooperVision, Inc.
2025-07-30Z-2168-2025Class IIMedtronic CareLink SmartSync Patient ConnectorMedtronic, Inc.
2025-07-30Z-2169-2025Class IIMedtronic CareLink SmartSync Device ManagerMedtronic, Inc.
2025-07-30Z-2170-2025Class IIStrykerStryker Corporation
2025-07-30Z-2171-2025Class IIStrykerStryker Corporation
2025-07-23Z-2095-2025Class IBaxter SIGMA Spectrum Infusion Pump V6Baxter Healthcare Corporation
2025-07-23Z-2096-2025Class IBaxter SIGMA Spectrum Infusion Pump V8Baxter Healthcare Corporation
2025-07-23Z-2102-2025Class Ii-view video laryngoscopeIntersurgical Inc
2025-07-23Z-2111-2025Class IILaser light show projectors manufactured by BLSBeyond Laser Systems, LLC
2025-07-23Z-2112-2025Class IILaser light show projectors manufactured by BLSBeyond Laser Systems, LLC
2025-07-23Z-2113-2025Class IILaser light show projectors manufactured by BLSBeyond Laser Systems, LLC
2025-07-23Z-2114-2025Class IINeuroSync EYE-SYNC containing Pico Neo 2 HeadsetsNeuroSync, Inc.
2025-07-23Z-2115-2025Class IIAccess Vitamin B12 ReagentBeckman Coulter, Inc.
2025-07-23Z-2116-2025Class IISwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeveICU Medical, Inc.
2025-07-23Z-2118-2025Class IIBrand Name: NIO-A Product Name: NIO Intraosseous Device Adult…Waismed Ltd.
2025-07-23Z-2119-2025Class IIBrand Name: NIO+ Product Name: NIO Intraosseous Device Adult…Waismed Ltd.
2025-07-23Z-2120-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry…Ortho-Clinical Diagnostics, Inc.
2025-07-23Z-2121-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry…Ortho-Clinical Diagnostics, Inc.
2025-07-23Z-2122-2025Class IIVITROS Chemistry Products CHE SlidesOrtho-Clinical Diagnostics, Inc.
2025-07-23Z-2123-2025Class IIVITROS Chemistry Products CHE SlidesOrtho-Clinical Diagnostics, Inc.
2025-07-23Z-2124-2025Class IIKWIK-STIK and LYFO DISKMicrobiologics Inc
2025-07-23Z-2125-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERTEncore Medical, LP
2025-07-23Z-2126-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERTEncore Medical, LP
2025-07-23Z-2127-2025Class IIMedtronic SmartLink Software loaded on SmartSync Patient ConnectorMedtronic, Inc.
2025-07-23Z-2128-2025Class IIMedtronic SmartLink software loaded on CareLink SmartSync Device…Medtronic, Inc.
2025-07-16Z-2031-2025Class IHillrom Q-Link 13 componentBaxter Healthcare Corporation
2025-07-16Z-2032-2025Class IHillrom LikoScale componentBaxter Healthcare Corporation
2025-07-16Z-2047-2025Class IBravo CF capsule delivery deviceGiven Imaging Ltd.
2025-07-16Z-2080-2025Class IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial…Edwards Lifesciences, LLC
2025-07-16Z-2081-2025Class IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial…Edwards Lifesciences, LLC
2025-07-16Z-2082-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula…Edwards Lifesciences, LLC
2025-07-16Z-2083-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula…Edwards Lifesciences, LLC
2025-07-16Z-2084-2025Class IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula…Edwards Lifesciences, LLC
2025-07-16Z-2085-2025Class IBrand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula…Edwards Lifesciences, LLC
2025-07-16Z-2090-2025Class IIITrueDent ClearSTRATASYS LTD
2025-07-16Z-2091-2025Class IIITrueDent CyanSTRATASYS LTD
2025-07-16Z-2092-2025Class IIITrueDent MagentaSTRATASYS LTD
2025-07-16Z-2093-2025Class IIITrueDent YellowSTRATASYS LTD
2025-07-16Z-2094-2025Class IIITrueDent WhiteSTRATASYS LTD
2025-07-16Z-2097-2025Class IIInfiniaGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-07-16Z-2098-2025Class IIVaricamGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-07-16Z-2099-2025Class IIBrand Name: Canturio¿ Smart Extension Product Name: CSE Implant…Canary Medical, Inc.
2025-07-16Z-2100-2025Class IIBrand Name: Hummingbird Product Name: Stimulated EMG Kit with…Neurovision Medical Products Inc
2025-07-16Z-2101-2025Class IIO-arm O2 Imaging SystemMedtronic Navigation, Inc.-Boxborough
2025-07-16Z-2103-2025Class IIVersaCross Access SolutionBoston Scientific Corporation
2025-07-16Z-2104-2025Class IIVersaCross RF WireBoston Scientific Corporation
2025-07-16Z-2105-2025Class IIVersaCross Transseptal Sheath KitBoston Scientific Corporation
2025-07-16Z-2106-2025Class IITorflex Transseptal Guiding Sheath KitBoston Scientific Corporation
2025-07-16Z-2107-2025Class IIPreatPreat Corp
2025-07-16Z-2108-2025Class IIBrand Name: Alcon LaboratoriesAlcon Research LLC
2025-07-16Z-2109-2025Class IIBrand Name: Alcon LaboratoriesAlcon Research LLC
2025-07-16Z-2110-2025Class IIBrand Name: Alcon LaboratoriesAlcon Research LLC
2025-07-09Z-2013-2025Class IServo-u Ventilator SystemMaquet Critical Care AB
2025-07-09Z-2014-2025Class IServo-n Ventilator SystemMaquet Critical Care AB
2025-07-09Z-2015-2025Class IServo-u MR Ventilator SystemMaquet Critical Care AB
2025-07-09Z-2019-2025Class IIARTIS is a family of dedicated angiography systems developed for…Siemens Medical Solutions USA, Inc
2025-07-09Z-2020-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc
2025-07-09Z-2021-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc
2025-07-09Z-2022-2025Class IIinterventional fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc
2025-07-09Z-2035-2025Class IBiPAP V30 Auto VentilatorPhilips Respironics, Inc.
2025-07-09Z-2036-2025Class IBiPAP A30 VentilatorsPhilips Respironics, Inc.
2025-07-09Z-2037-2025Class IBiPAP A40 VentilatorPhilips Respironics, Inc.
2025-07-09Z-2038-2025Class IIBrand Name: VITROS Product Name: VITROS 5600 Integrated System…Ortho-Clinical Diagnostics, Inc.
2025-07-09Z-2039-2025Class IIBrand Name: VITROSOrtho-Clinical Diagnostics, Inc.
2025-07-09Z-2040-2025Class IIBrand Name: VITROS Product Name: VITROS 4600 Chemistry System…Ortho-Clinical Diagnostics, Inc.
2025-07-09Z-2041-2025Class IIHardyCHROM CREHardy Diagnostics
2025-07-09Z-2042-2025Class IIMy3D Personalized Solutions Humeral CupOnkos Surgical, Inc.
2025-07-09Z-2043-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV…MEDLINE INDUSTRIES, LP - Northfield
2025-07-09Z-2044-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV…MEDLINE INDUSTRIES, LP - Northfield
2025-07-09Z-2045-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV…MEDLINE INDUSTRIES, LP - Northfield
2025-07-09Z-2046-2025Class IIIBrand Name: Valeda Light Delivery System Product Name: Light Based…LUMITHERA INC
2025-07-09Z-2048-2025Class IIPhilips 3D9-3v TransducerPhilips Ultrasound, Inc
2025-07-09Z-2049-2025Class IIPhilips C5-1 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2050-2025Class IIPhilips C5-2 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2051-2025Class IIPhilips C9-5EC TransducerPhilips Ultrasound, Inc
2025-07-09Z-2052-2025Class IIPhilips eL18-4 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2053-2025Class IIPhilips eL18-4 EMT TransducerPhilips Ultrasound, Inc
2025-07-09Z-2054-2025Class IIPhilips L12-3 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2055-2025Class IIPhilips L12-4 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2056-2025Class IIPhilips L8-4 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2057-2025Class IIPhilips L9-3 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2058-2025Class IIPhilips S5-1 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2059-2025Class IIPhilips S7-2 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2060-2025Class IIPhilips S7-3t TransducerPhilips Ultrasound, Inc
2025-07-09Z-2061-2025Class IIPhilips S8-3t TransducerPhilips Ultrasound, Inc
2025-07-09Z-2062-2025Class IIPhilips V6-2 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2063-2025Class IIPhilips VL13-5 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2064-2025Class IIPhilips X5-1 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2065-2025Class IIPhilips X6-1 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2066-2025Class IIPhilips X7-2t TransducerPhilips Ultrasound, Inc
2025-07-09Z-2067-2025Class IIPhilips X8-2t TransducerPhilips Ultrasound, Inc
2025-07-09Z-2068-2025Class IIPhilips XL14-3 TransducerPhilips Ultrasound, Inc
2025-07-09Z-2069-2025Class IIApex Knee SystemCORIN MEDICAL, LTD.
2025-07-09Z-2070-2025Class IIThe HemoCue Glucose 201 Microcuvettes are designed for use with the…HemoCue AB
2025-07-09Z-2071-2025Class IIChange Healthcare Cardiology Hemo SoftwareCHANGE HEALTHCARE CANADA COMPANY
2025-07-09Z-2072-2025Class IIChange Healthcare Cardiology Hemodynamics SoftwareCHANGE HEALTHCARE CANADA COMPANY
2025-07-09Z-2073-2025Class IIVITROS Chemistry Products OP Reagent Gen 15Ortho-Clinical Diagnostics, Inc.
2025-07-09Z-2074-2025Class IIBD Heyman Follower Straight Tip for following sizes: 10FrC.R. Bard Inc
2025-07-09Z-2075-2025Class IIBD Heyman Follower Coude Tip for following sizes: 12FrC.R. Bard Inc
2025-07-09Z-2076-2025Class IIREF: 123400C.R. Bard Inc
2025-07-09Z-2077-2025Class IIColoSense Test KitGeneoscopy, Inc.
2025-07-09Z-2078-2025Class IIREF: 335775Becton, Dickinson and Company, BD Bio Sciences
2025-07-09Z-2079-2025Class IIREF: 666289Becton, Dickinson and Company, BD Bio Sciences
2025-07-09Z-2086-2025Class IIADVIA¿ 120/2120/2120i SETpoint CalibratorSiemens Healthcare Diagnostics, Inc.
2025-07-09Z-2087-2025Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint ControlSiemens Healthcare Diagnostics, Inc.
2025-07-09Z-2088-2025Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint ControlSiemens Healthcare Diagnostics, Inc.
2025-07-09Z-2089-2025Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint ControlSiemens Healthcare Diagnostics, Inc.
2025-07-02Z-1904-2025Class IBroselow Pediatric Emergency Rainbow TapeSunMed Holdings, LLC
2025-07-02Z-1958-2025Class IExtended Tip ApplicatorIntegra LifeSciences Corp. (NeuroSciences)
2025-07-02Z-1959-2025Class IExtended Tip ApplicatorIntegra LifeSciences Corp. (NeuroSciences)
2025-07-02Z-1960-2025Class IExtended Tip Applicator 8CMIntegra LifeSciences Corp. (NeuroSciences)
2025-07-02Z-1961-2025Class IMicroMyst ApplicatorIntegra LifeSciences Corp. (NeuroSciences)
2025-07-02Z-1994-2025Class IIModel: Description/REF: MNA-420: MNA-420 ENC -H/K9303320Barco N.V.
2025-07-02Z-1995-2025Class IIMedline UMBILICAL TRAY W/3MEDLINE INDUSTRIES, LP - Northfield
2025-07-02Z-1996-2025Class IIDxI 9000 Access Immunoassay Analyzer C11137Beckman Coulter, Inc.
2025-07-02Z-1997-2025Class IIBigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject…BIGFOOT BIOMEDICAL

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