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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-10-22Z-0085-2026Class IPROPONENT SR SLBoston Scientific Corporation
2025-10-22Z-0086-2026Class IPROPONENT DR SLBoston Scientific Corporation
2025-10-22Z-0087-2026Class IModel Number L209 PROPONENT DRBoston Scientific Corporation
2025-10-22Z-0088-2026Class IModel Number L210 PROPONENT SR SL PacemakerBoston Scientific Corporation
2025-10-22Z-0089-2026Class IModel Number L211 PROPONENT DR SL MRI PacemakerBoston Scientific Corporation
2025-10-22Z-0090-2026Class IModel Number L221 PROPONENT DR EL PacemakerBoston Scientific Corporation
2025-10-22Z-0091-2026Class IModel Number L231Boston Scientific Corporation
2025-10-22Z-0092-2026Class IModel Number L100Boston Scientific Corporation
2025-10-22Z-0093-2026Class IModel Number L101Boston Scientific Corporation
2025-10-22Z-0094-2026Class IModel Number L110Boston Scientific Corporation
2025-10-22Z-0095-2026Class IModel Number L111Boston Scientific Corporation
2025-10-22Z-0096-2026Class IModel Number L121 ESSENTIO DR EL PacemakerBoston Scientific Corporation
2025-10-22Z-0097-2026Class IModel Number L131Boston Scientific Corporation
2025-10-22Z-0098-2026Class IModel Number S701 ALTRUA 2 SR SL PacemakerBoston Scientific Corporation
2025-10-22Z-0099-2026Class IModel Number S702Boston Scientific Corporation
2025-10-22Z-0100-2026Class IModel Number S722Boston Scientific Corporation
2025-10-22Z-0101-2026Class IModel Number U125Boston Scientific Corporation
2025-10-22Z-0102-2026Class IModel Number U128Boston Scientific Corporation
2025-10-22Z-0103-2026Class IModel Number U225 VISIONIST CRT-P ELBoston Scientific Corporation
2025-10-22Z-0104-2026Class IModel Number U226Boston Scientific Corporation
2025-10-22Z-0105-2026Class IModel Number U228Boston Scientific Corporation
2025-10-22Z-0108-2026Class IIFlow Re-Direction Endoluminal Devices: FRED 27MICROVENTION INC.
2025-10-22Z-0109-2026Class ITactiFlex Sensor Enabled Ablation CatheterAbbott
2025-10-22Z-0110-2026Class ITactiFlex Sensor Enabled Ablation CatheterAbbott
2025-10-22Z-0111-2026Class ITactiFlex Sensor Enabled Ablation CatheterAbbott
2025-10-22Z-0112-2026Class ITactiFlex Sensor Enabled Ablation CatheterAbbott
2025-10-22Z-0113-2026Class ITactiFlex Sensor Enabled Ablation CatheterAbbott
2025-10-22Z-0131-2026Class IINeuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System…Contego Medical LLC
2025-10-22Z-0132-2026Class IIThe failure occurs if a user on the Omnipod 5 iOS application selects…Insulet Corporation
2025-10-22Z-0133-2026Class IIFERNO POWER X2 POWERED AMBULANCE COTFerno-Washington Inc
2025-10-22Z-0134-2026Class IICyclopen Microinterventional Cyclodialysis SystemIantrek Inc.
2025-10-22Z-0135-2026Class IIC-Rex UNO Microinterventional Goniotomy InstrumentIantrek Inc.
2025-10-22Z-0137-2026Class IIMedline Adult Anesthesia SetMedline Industries, LP
2025-10-22Z-0138-2026Class IITENACIO Pump with InhibiZoneBoston Scientific Corporation
2025-10-22Z-0139-2026Class IITENACIO Pump without InhibiZoneBoston Scientific Corporation
2025-10-22Z-0140-2026Class IICX Preconnect with TENACIO Pump without InhibiZoneBoston Scientific Corporation
2025-10-22Z-0141-2026Class IILGX Preconnect with TENACIO Pump without InhibiZoneBoston Scientific Corporation
2025-10-22Z-0142-2026Class IICX Preconnect with TENACIO Pump with InhibiZoneBoston Scientific Corporation
2025-10-22Z-0143-2026Class IICXR Preconnect with TENACIO Pump with InhibiZoneBoston Scientific Corporation
2025-10-22Z-0144-2026Class IILGX Preconnect with TENACIO Pump with InhibiZoneBoston Scientific Corporation
2025-10-22Z-0145-2026Class IIBrand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number:…Kico Knee Innovation Company
2025-10-22Z-0146-2026Class IIXERF EFFECTOR 60Lutronic Corporation
2025-10-22Z-0147-2026Class IIECHELON LINEAR Cutters Reload 80 mm BlueEthicon Endo-Surgery Inc
2025-10-22Z-0148-2026Class IIBioPro Femoral HeadBioPro, Inc.
2025-10-22Z-0149-2026Class IIBioPro Endo HeadBioPro, Inc.
2025-10-22Z-0150-2026Class IIBioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM…BioPro, Inc.
2025-10-22Z-0151-2026Class IIBioPro Femoral HeadBioPro, Inc.
2025-10-22Z-0152-2026Class IIBioPro Endo HeadBioPro, Inc.
2025-10-22Z-0153-2026Class IIBioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH…BioPro, Inc.
2025-10-22Z-0155-2026Class IILOGIQ P10 series with software version R4GE Medical Systems, LLC
2025-10-22Z-0156-2026Class IILOGIQ P10 R4GE Medical Systems, LLC
2025-10-22Z-0157-2026Class IILOGIQ P9 R4GE Medical Systems, LLC
2025-10-22Z-0158-2026Class IIAirvo 2Fisher & Paykel Healthcare, Ltd.
2025-10-22Z-0160-2026Class IIDuoDERM" Extra Thin dressings are highly flexibleConvaTec, Inc
2025-10-22Z-0165-2026Class IICardiac Workstation 5000Philips North America
2025-10-22Z-0166-2026Class IICardiac Workstation 7000Philips North America
2025-10-22Z-0167-2026Class IIBrand Name: Branding is not applied to this productSpacelabs Healthcare, Inc.
2025-10-22Z-0168-2026Class IIBrand Name: Branding is not applied to this productSpacelabs Healthcare, Inc.
2025-10-22Z-0169-2026Class IIBrand Name: Branding is not applied to this productSpacelabs Healthcare, Inc.
2025-10-22Z-0170-2026Class IIBasic Biopsy TrayAmerican Contract Systems Inc.
2025-10-22Z-0171-2026Class IIBasic Biopsy TrayAmerican Contract Systems Inc.
2025-10-22Z-0172-2026Class IIMedical convenience kits Item number/ Product description AKGN82E…American Contract Systems Inc.
2025-10-22Z-0173-2026Class IIMedical convenience kits Item number/ Product description AHLD15X…American Contract Systems Inc.
2025-10-22Z-0174-2026Class IIMedical convenience kits Item Number/Description BUCY78E CYSTO PACK…American Contract Systems Inc.
2025-10-22Z-0175-2026Class IIMedical convenience kits Item Number/Description EVLH67F LEFT HEART…American Contract Systems Inc.
2025-10-22Z-0176-2026Class IIMedical convenience kits Item Number/Description ANCV78BC HEART PACKAmerican Contract Systems Inc.
2025-10-22Z-0177-2026Class IIMedical convenience kits Item Number/Description UICL44P ADULT…American Contract Systems Inc.
2025-10-22Z-0178-2026Class IIMedical convenience kits Item Number/Description RCEN25B ENT SDSC…American Contract Systems Inc.
2025-10-22Z-0179-2026Class IIMedical convenience kits Item Number/Description RCGY52D GYN…American Contract Systems Inc.
2025-10-22Z-0180-2026Class IIMedical convenience kits Item Number/Description HSAN63N ANGIO PACK…American Contract Systems Inc.
2025-10-22Z-0181-2026Class IIMedical convenience kits Item Number/Description FHCP08Y C SECTION PK…American Contract Systems Inc.
2025-10-22Z-0182-2026Class IIMedical convenience kits Item Number/Description LKRA40G RADIOLOGY…American Contract Systems Inc.
2025-10-22Z-0183-2026Class IIMedical convenience kits Item Number/Description HSLM53AB SPINE PACK…American Contract Systems Inc.
2025-10-22Z-0184-2026Class IIMedical convenience kits Item Number/Description ANSH14AF SHOULDER…American Contract Systems Inc.
2025-10-22Z-0185-2026Class IIMedical convenience kits Item Number/Description BFCT04X CATARACT PACKAmerican Contract Systems Inc.
2025-10-22Z-0186-2026Class IIMedical convenience kits UDPG88W PICC G-TUBE PACK-230209American Contract Systems Inc.
2025-10-22Z-0187-2026Class IIMedical convenience kits IHDC30R D AND C PACKAmerican Contract Systems Inc.
2025-10-22Z-0189-2026Class IICONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0190-2026Class IICLEARLINK System Solution SetBaxter Healthcare Corporation
2025-10-22Z-0191-2026Class IICLEARLINK SYSTEM Solution SetBaxter Healthcare Corporation
2025-10-22Z-0192-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0193-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0194-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0195-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0196-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0197-2026Class IICLEARLINK SYSTEM EXTENSION SETBaxter Healthcare Corporation
2025-10-22Z-0198-2026Class IICLEARLINK SYSTEM EXTENSION SETBaxter Healthcare Corporation
2025-10-22Z-0199-2026Class IICLEARLINK SYSTEM EXTENSION SETBaxter Healthcare Corporation
2025-10-22Z-0200-2026Class IICLEARLINK System Non_DEHP Extenstion SetBaxter Healthcare Corporation
2025-10-22Z-0201-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0202-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution SetBaxter Healthcare Corporation
2025-10-22Z-0203-2026Class IICLEARLINK System Paclitaxel SetBaxter Healthcare Corporation
2025-10-22Z-0204-2026Class IICLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SETBaxter Healthcare Corporation
2025-10-22Z-0205-2026Class IIProduct: STA Liatest D-DiDiagnostica Stago, Inc.
2025-10-15Z-0028-2026Class INOxBOXi Nitric Oxide Delivery SystemNOXBOX LTD
2025-10-15Z-0029-2026Class INOxBOXi Nitric Oxide Delivery SystemNOXBOX LTD
2025-10-15Z-0035-2026Class IBD Alaris Pump Infusion Sets for the following reference numbers:…CareFusion 303, Inc.
2025-10-15Z-0037-2026Class IIThis device is a digital radiography/fluoroscopy system used in a…Canon Medical System, USA, INC.
2025-10-15Z-0038-2026Class IIClariTEE Miniaturized TEE probeImaCor Inc.
2025-10-15Z-0039-2026Class IICorNeat EverPatchCORNEAT VISION, LTD.
2025-10-15Z-0040-2026Class IIEverPatch+CORNEAT VISION, LTD.
2025-10-15Z-0041-2026Class IIOptiflux¿ High Flux E-beam Dialyzer Model Numbers:Fresenius Medical Care Holdings, Inc.
2025-10-15Z-0044-2026Class IIFDR Visionary SuiteFUJIFILM Healthcare Americas Corporation
2025-10-15Z-0068-2026Class IIAW Server 2GE Medical Systems, SCS
2025-10-15Z-0069-2026Class IAutomated Impella ControllerAbiomed, Inc.
2025-10-15Z-0071-2026Class IISYNCHRON Systems PhosphorusBeckman Coulter Inc.
2025-10-15Z-0072-2026Class IIArtegraft Collagen Vascular GraftLeMaitre Vascular, Inc.
2025-10-15Z-0106-2026Class IIFlexLabInpeco S.A.
2025-10-15Z-0107-2026Class IIFlexLab XInpeco S.A.
2025-10-15Z-0114-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 GaB BRAUN MEDICAL INC
2025-10-15Z-0115-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 GaB BRAUN MEDICAL INC
2025-10-15Z-0116-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 GaB BRAUN MEDICAL INC
2025-10-15Z-0117-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 GaB BRAUN MEDICAL INC
2025-10-15Z-0118-2026Class IIPERIFIX FX Continuous Epidural Anesthesia TrayB BRAUN MEDICAL INC
2025-10-15Z-0119-2026Class IIPERIFIX FX Continuous Epidural Anesthesia TrayB BRAUN MEDICAL INC
2025-10-15Z-0120-2026Class IIPERIFIX FX Continuous Epidural Anesthesia TrayB BRAUN MEDICAL INC
2025-10-15Z-0121-2026Class IIPERIFIX FX Continuous Epidural Anesthesia SetB BRAUN MEDICAL INC
2025-10-15Z-0122-2026Class IIESPOCAN Combined Spinal and Epidural Anesthesia TrayB BRAUN MEDICAL INC
2025-10-15Z-0123-2026Class IICombined Spinal and Epidural Anesthesia TrayB BRAUN MEDICAL INC
2025-10-15Z-0124-2026Class IIDesign OptionsB BRAUN MEDICAL INC
2025-10-15Z-0125-2026Class IICombined Spinal and Epidural Anesthesia Tray 2B BRAUN MEDICAL INC
2025-10-15Z-0126-2026Class IIDesign OptionsB BRAUN MEDICAL INC
2025-10-15Z-0127-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFitApplied Medical Technology Inc
2025-10-15Z-0128-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFitApplied Medical Technology Inc
2025-10-15Z-0129-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFitApplied Medical Technology Inc
2025-10-15Z-0130-2026Class IINutraGlide Nasal Feeding Tube with Stylet and ENFitApplied Medical Technology Inc
2025-10-08Z-0001-2026Class IIAllura Xper FD10CPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0002-2026Class IIAllura Xper FD10PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0003-2026Class IIAllura Xper FD10/10PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0004-2026Class IIAllura Xper FD10 OR TablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0005-2026Class IIAllura Xper FD20PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0006-2026Class IIAllura Xper FD20 BiplanePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0007-2026Class IIAllura Xper FD20 Biplane OR TablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0008-2026Class IIAllura Xper FD20 OR TablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0009-2026Class IIAllura Xper FD20/10PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0010-2026Class IIAllura Xper FD20/15PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0011-2026Class IIAllura Xper FD20/15 OR TablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0012-2026Class IIAllura Xper FD20/20PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0013-2026Class IIAllura Xper FD20/20 OR TablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0014-2026Class IIAllura Xper CV20PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0015-2026Class IICardio Vascular-Allura CentronPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-10-08Z-0016-2026Class IIGetinge 88-Series Washer- DisinfectorGetinge Disinfection Ab
2025-10-08Z-0017-2026Class IIIMPLANT EPIKUT PLUS MT16 3S.I.N. Implant System Ltda
2025-10-08Z-0018-2026Class IINES Reprocessed 0Northeast Scientific Inc.
2025-10-08Z-0019-2026Class IINES Reprocessed 1Northeast Scientific Inc.
2025-10-08Z-0020-2026Class IINES Reprocessed 1Northeast Scientific Inc.
2025-10-08Z-0021-2026Class IINES Reprocessed 2Northeast Scientific Inc.
2025-10-08Z-0022-2026Class IINES Reprocessed 0Northeast Scientific Inc.
2025-10-08Z-0023-2026Class IINES Reprocessed 1Northeast Scientific Inc.
2025-10-08Z-0024-2026Class IINES Reprocessed 1Northeast Scientific Inc.
2025-10-08Z-0025-2026Class IINES Reprocessed 2Northeast Scientific Inc.
2025-10-08Z-0026-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD STANDARDAesculap AG
2025-10-08Z-0027-2026Class IIAESCULAP ELAN 4 FIXED DURAGUARD LONGAesculap AG
2025-10-08Z-0030-2026Class IIChange Healthcare Radiology Solutions software version 14CHANGE HEALTHCARE CANADA COMPANY
2025-10-08Z-0032-2026Class IIDxC 500 AU Module w/ISEBeckman Coulter Inc.
2025-10-08Z-0033-2026Class IIMedtronicMedtronic MiniMed, Inc.
2025-10-08Z-0034-2026Class IIArtegraft Collagen Vascular Grafts Model Numbers:LeMaitre Vascular, Inc.
2025-10-08Z-0036-2026Class IIGORE ACUSEAL Vascular GraftW L Gore & Associates, Inc.
2025-10-08Z-2592-2025Class ISterile Medline Convenience Kits: 1) MAJOR PACK L-FMedline Industries, LP
2025-10-08Z-2593-2025Class ISterile Medline Convenience Kits: 1) EXTREMITY PACKMedline Industries, LP
2025-10-08Z-2610-2025Class IReprocessed Livewire Steerable Electrophysiology Catheter Item…Medline Industries, LP
2025-10-08Z-2611-2025Class IReprocessed Webster CS Catheter 10 Electrodes for…Medline Industries, LP
2025-10-08Z-2612-2025Class IReprocessed Inquiry Steerable Diagnostics Catheter for electrogram…Medline Industries, LP
2025-10-08Z-2613-2025Class IReprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structuresMedline Industries, LP
2025-10-08Z-2614-2025Class IReprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and…Medline Industries, LP
2025-10-08Z-2616-2025Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number:…Draeger, Inc.
2025-10-08Z-2617-2025Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number:…Draeger, Inc.
2025-10-08Z-2637-2025Class IIJUNCTIONAL EMERGENCY TREATMENT TOOLNorth American Rescue LLC.
2025-10-08Z-2638-2025Class IIVenclose digiRF GeneratorsBard Peripheral Vascular Inc
2025-10-08Z-2639-2025Class IIZAP-X Radiosurgery SystemZap Surgical Systems
2025-10-08Z-2640-2025Class II1Howmedica Osteonics Corp.
2025-10-08Z-2654-2025Class IBiograph mMRSiemens Medical Solutions USA, Inc
2025-10-08Z-2655-2025Class IBIOGRAPH OneSiemens Medical Solutions USA, Inc
2025-10-08Z-2656-2025Class IMAGNETOM CimaSiemens Medical Solutions USA, Inc
2025-10-08Z-2657-2025Class IMAGNETOM ConnectomSiemens Medical Solutions USA, Inc
2025-10-08Z-2658-2025Class IMAGNETOM LuminaSiemens Medical Solutions USA, Inc
2025-10-08Z-2659-2025Class IMAGNETOM PrismaSiemens Medical Solutions USA, Inc
2025-10-08Z-2660-2025Class IMAGNETOM SkyraSiemens Medical Solutions USA, Inc
2025-10-08Z-2661-2025Class IMAGNETOM Skyra fitSiemens Medical Solutions USA, Inc
2025-10-08Z-2662-2025Class IMAGNETOM Skyra Fit BioMatrixSiemens Medical Solutions USA, Inc
2025-10-08Z-2663-2025Class IMAGNETOM Spectra as the following: 1Siemens Medical Solutions USA, Inc
2025-10-08Z-2664-2025Class IMAGNETOM VerioSiemens Medical Solutions USA, Inc
2025-10-08Z-2665-2025Class IMAGNETOM Verio DotSiemens Medical Solutions USA, Inc
2025-10-08Z-2666-2025Class IMAGNETOM Verio Dot UpgradeSiemens Medical Solutions USA, Inc
2025-10-08Z-2667-2025Class IMAGNETOM VidaSiemens Medical Solutions USA, Inc
2025-10-08Z-2668-2025Class IMAGNETOM Vida FitSiemens Medical Solutions USA, Inc
2025-10-08Z-2670-2025Class IMedline Kits: 1) VALVE PACK-LFMedline Industries, LP
2025-10-08Z-2671-2025Class IIVITEK¿ 2 Gram-negative AST Test KitsbioMerieux, Inc.
2025-10-08Z-2672-2025Class IIArgus PB-3000Schiller, Ag
2025-10-08Z-2673-2025Class IIAshvins variant HEYEX 2 / HEYEX PACSMedicalCommunications GmbH
2025-10-01Z-2566-2025Class IMedline medical convenience kits labeled as: 1MEDLINE INDUSTRIES, LP - Northfield
2025-10-01Z-2567-2025Class IMedline medical convenience kits labeled as: 1MEDLINE INDUSTRIES, LP - Northfield
2025-10-01Z-2568-2025Class IAutomated Impella ControllerAbiomed, Inc.
2025-10-01Z-2594-2025Class IIBaster Continu-Flo Solution SetBaxter Healthcare Corporation
2025-10-01Z-2595-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc
2025-10-01Z-2596-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc
2025-10-01Z-2597-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc
2025-10-01Z-2598-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc
2025-10-01Z-2599-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc
2025-10-01Z-2600-2025Class IIPhilips CT systems labeled as the following: 1Philips North America Llc

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