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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-06-04Z-1880-2025Class IISegmental StemOnkos Surgical, Inc.
2025-06-04Z-1881-2025Class IISegmental StemOnkos Surgical, Inc.
2025-06-04Z-1882-2025Class IISegmental StemOnkos Surgical, Inc.
2025-06-04Z-1883-2025Class IIEthos Collar StemOnkos Surgical, Inc.
2025-06-04Z-1884-2025Class IIMale-Female Midsection with the following sizes and model numbersOnkos Surgical, Inc.
2025-05-28Z-1746-2025Class IEndopath Echelon Vascular White Reload for Advanced Placement TipEthicon Endo-Surgery Inc
2025-05-28Z-1755-2025Class IBard Minnesota Four Lumen Esophagogastric Tamponade TubeC.R. Bard Inc
2025-05-28Z-1756-2025Class IBard Blakemore Esophageal-Nasogastric TubeC.R. Bard Inc
2025-05-28Z-1757-2025Class IBard¿ Blakemore Esophageal-Nasogastric TubeC.R. Bard Inc
2025-05-28Z-1758-2025Class IBard¿ Blakemore Esophageal-Nasogastric TubeC.R. Bard Inc
2025-05-28Z-1759-2025Class IBard¿ Single Intragastric Linton Balloon TubeC.R. Bard Inc
2025-05-28Z-1760-2025Class ICenterline Biomedical IOPS Guidewire 2Centerline Biomedical Inc
2025-05-28Z-1767-2025Class IBaxter Novum IQ LVP INFUSION SYSTEMBaxter Healthcare Corporation
2025-05-28Z-1785-2025Class IITrue 3D ViewerEchopixel, Inc.
2025-05-28Z-1786-2025Class IICheck=Flo Performer IntroducerCook Incorporated
2025-05-28Z-1787-2025Class IICheck=Flo Performer IntroducerCook Incorporated
2025-05-28Z-1788-2025Class IIProduct Name: SmartPath to dStream for 1Philips North America Llc
2025-05-28Z-1789-2025Class IIProduct Name: SmartPath to dStream for 3Philips North America Llc
2025-05-28Z-1790-2025Class IIProduct Name: SmartPath to dStream for XR and 3Philips North America Llc
2025-05-28Z-1791-2025Class IIProduct Name: SmartPath to Ingenia Elition XPhilips North America Llc
2025-05-28Z-1792-2025Class IIProduct Name: Upgrade to MR 7700Philips North America Llc
2025-05-28Z-1793-2025Class IIProduct Name: Evolution Upgrade 1Philips North America Llc
2025-05-28Z-1794-2025Class IIProduct Name: Evolution Upgrade 3Philips North America Llc
2025-05-28Z-1795-2025Class IIProduct Name: Ingenia 1Philips North America Llc
2025-05-28Z-1796-2025Class IIProduct Name: Ingenia 1Philips North America Llc
2025-05-28Z-1797-2025Class IIProduct Name: Ingenia 3Philips North America Llc
2025-05-28Z-1798-2025Class IIProduct Name: Ingenia Ambition SPhilips North America Llc
2025-05-28Z-1799-2025Class IIProduct Name: Ingenia 1Philips North America Llc
2025-05-28Z-1800-2025Class IIProduct Name: Ingenia 3Philips North America Llc
2025-05-28Z-1801-2025Class IIProduct Name: Ingenia Ambition XPhilips North America Llc
2025-05-28Z-1802-2025Class IIProduct Name: Ingenia Elition SPhilips North America Llc
2025-05-28Z-1803-2025Class IIProduct Name: Ingenia Elition XPhilips North America Llc
2025-05-28Z-1804-2025Class IIProduct Name: MR 5300Philips North America Llc
2025-05-28Z-1805-2025Class IIProduct Name: MR 7700Philips North America Llc
2025-05-28Z-1806-2025Class IIMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MMSmith & Nephew, Inc.
2025-05-28Z-1807-2025Class IITRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1Echopixel, Inc.
2025-05-28Z-1808-2025Class IIBD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1Becton Dickinson Infusion Therapy Systems, Inc.
2025-05-28Z-1812-2025Class IIPhenoMATRIXCopan WASP
2025-05-28Z-1813-2025Class IIHiResolution" Bionic Ear SystemAdvanced Bionics, LLC
2025-05-21Z-1697-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…Vyaire Medical
2025-05-21Z-1698-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…Vyaire Medical
2025-05-21Z-1725-2025Class IWelch Allyn Life2000 Ventilation systemBaxter Healthcare Corporation
2025-05-21Z-1726-2025Class IWelch Allyn Life2000 CompressorBaxter Healthcare Corporation
2025-05-21Z-1727-2025Class IiGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen…Medical Depot Inc.
2025-05-21Z-1730-2025Class IMedicaLyte Liquid Bicarbonate ConcentrateNipro Renal Soultions USA, Corporation
2025-05-21Z-1741-2025Class IIHalyard CHRIST SUTURE KITAVID Medical, Inc.
2025-05-21Z-1742-2025Class IIHalyard SUTURE PACK CABGAVID Medical, Inc.
2025-05-21Z-1743-2025Class IIHalyard RAPIDES E-PACKAVID Medical, Inc.
2025-05-21Z-1744-2025Class IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight…Meddev Corp
2025-05-21Z-1745-2025Class IIBrand Name: Contour Product Name: Contour Gold Eyelid Weight…Meddev Corp
2025-05-21Z-1747-2025Class IIFoundationOne Companion DiagnosticFoundation Medicine, Inc.
2025-05-21Z-1748-2025Class IIAlinity m Resp-4-Plex AmplificationAbbott Molecular, Inc.
2025-05-21Z-1749-2025Class IIAlinity m Resp-4-Plex AMP KitAbbott Molecular, Inc.
2025-05-21Z-1750-2025Class IITufTex Over-the-Wire Embolectomy CatheterLeMaitre Vascular, Inc.
2025-05-21Z-1751-2025Class IIPruitt Occlusion CatheterLeMaitre Vascular, Inc.
2025-05-21Z-1752-2025Class IIPruitt Irrigation Occlusion CatheterLeMaitre Vascular, Inc.
2025-05-21Z-1753-2025Class IIPiezoWave 2 Control UnitRichard Wolf GmbH
2025-05-21Z-1754-2025Class IIBIB Balloon in Balloon Dilatation CatheterNumed Inc
2025-05-21Z-1761-2025Class IIAugmedics Perc Pin AdaptorAugmedics Ltd.
2025-05-21Z-1762-2025Class IITornado Embolization MicrocoilCook Incorporated
2025-05-21Z-1763-2025Class IILifeShield Drug Library ManagementICU Medical, Inc.
2025-05-21Z-1764-2025Class IICMS8000 Patient MonitorContec Medical Systems Co., Ltd.
2025-05-21Z-1765-2025Class IICenturion Sterile Weitlaner RetractorMEDLINE INDUSTRIES, LP - Northfield
2025-05-21Z-1766-2025Class IICenturion Sterile Weitlaner Retractor 3 x 4 ProngMEDLINE INDUSTRIES, LP - Northfield
2025-05-21Z-1768-2025Class IIKliniTrayKlinika Mdical Gmb
2025-05-21Z-1769-2025Class IIKliniTray Platte FaxitronKlinika Mdical Gmb
2025-05-21Z-1770-2025Class IIEnterprise 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1771-2025Class IIIntera 0PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1772-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1773-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1774-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1775-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1776-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1777-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1778-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1779-2025Class IIIntera 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1780-2025Class IIIntera 3PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1781-2025Class IIIntera CVPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1782-2025Class IISmartPath to dStream for 1PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1783-2025Class IISmartPath to dStream for 3PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2025-05-21Z-1784-2025Class IIDxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Inc.
2025-05-14Z-1662-2025Class ICADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply…Smiths Medical ASD, Inc.
2025-05-14Z-1667-2025Class ICADD-Solis HPCA Ambulatory Infusion PumpSmiths Medical ASD, Inc.
2025-05-14Z-1668-2025Class ICADD-Solis VIP Ambulatory Infusion PumpSmiths Medical ASD, Inc.
2025-05-14Z-1679-2025Class IIntraocular lensBausch & Lomb Surgical, Inc.
2025-05-14Z-1680-2025Class IIntraocular LensBausch & Lomb Surgical, Inc.
2025-05-14Z-1681-2025Class ICADD-Solis Infusion Pump Models: 1) PUMP KITSmiths Medical ASD, Inc.
2025-05-14Z-1682-2025Class ICADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KITSmiths Medical ASD, Inc.
2025-05-14Z-1716-2025Class ICODMAN Disposable PerforatorIntegra LifeSciences Corp. (NeuroSciences)
2025-05-14Z-1717-2025Class ICODMAN Craniotomy KitIntegra LifeSciences Corp. (NeuroSciences)
2025-05-14Z-1718-2025Class IIBio 1 Granules for Filling ¿ 1 mmSCIENCE & BIO MATERIALS
2025-05-14Z-1719-2025Class IIMeridian Bioscience ImmunoCard STAT! Crypto/Giardia Test KitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-14Z-1720-2025Class IIWasher Disinfector Aquadis 56Getinge Disinfection Ab
2025-05-14Z-1721-2025Class IIWasher Disinfector Aquadis 56Getinge Disinfection Ab
2025-05-14Z-1722-2025Class IIMicrostream Advance Neonatal-Infant Intubated CO2 Filter Line…Philips North America Llc
2025-05-14Z-1723-2025Class IIAmbu aScope" 5 Broncho HD 5Ambu Inc.
2025-05-14Z-1724-2025Class IIINSPIRA AIR BALLOON DILATION SYSTEM 10x40Integra LifeSciences Corp. (NeuroSciences)
2025-05-14Z-1728-2025Class IIArtix MT Thrombectomy DeviceInari Medical - Oak Canyon
2025-05-14Z-1729-2025Class IIPhilips Tempus Pro Patient MonitorRemote Diagnostic Technologies Ltd.
2025-05-14Z-1731-2025Class IIGALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is…Galt Medical Corporation
2025-05-14Z-1732-2025Class IIB Braun Interventional Coaxial Dilator REF: KIT-018-47Galt Medical Corporation
2025-05-14Z-1733-2025Class IIB Braun Interventional ELITE HV Hemostasis Valve Introducer System…Galt Medical Corporation
2025-05-14Z-1734-2025Class IIGALT Guidewire REF SGW-051-07 Guidewires are intended for use in…Galt Medical Corporation
2025-05-14Z-1735-2025Class IIIntroducer Kit- Coaxial Dilator REF: KIT-002-28Galt Medical Corporation
2025-05-14Z-1736-2025Class IIIntroducer Needle REF NDL-107-04 These needles are used for the…Galt Medical Corporation
2025-05-14Z-1737-2025Class IIIntroducer Kit- Tearaway MicroSlide REF KIT-051-01Galt Medical Corporation
2025-05-14Z-1738-2025Class IIBlueprint SoftwareTornier S.A.S.
2025-05-14Z-1739-2025Class IIAtalante XWANDERCRAFT SAS
2025-05-14Z-1740-2025Class IIIntelliSpace Cardiovascular software versions 6Philips Medical Systems Nederland B.V.
2025-05-07Z-1624-2025Class IGE Healthcare CARESTATION 620 A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1625-2025Class IGE Healthcare CARESTATION 620 A2GE Medical Systems China Co., Ltd.
2025-05-07Z-1626-2025Class IGE Healthcare Carestation 620 SEGE Medical Systems China Co., Ltd.
2025-05-07Z-1627-2025Class IGE Healthcare Carestation 620 A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1628-2025Class IGE Healthcare CARESTATION 650 A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1629-2025Class IGE Healthcare CARESTATION 650 A2GE Medical Systems China Co., Ltd.
2025-05-07Z-1630-2025Class IGE Healthcare Carestation 650 SEGE Medical Systems China Co., Ltd.
2025-05-07Z-1631-2025Class IGE Healthcare Carestation 650 A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1632-2025Class IGE Healthcare CARESTATION 650C A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1633-2025Class IGE Healthcare CARESTATION 650C A2GE Medical Systems China Co., Ltd.
2025-05-07Z-1634-2025Class IGE Healthcare Carestation 650c A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1635-2025Class IGE Healthcare CARESTATION 750 A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1636-2025Class IGE Healthcare CARESTATION 750 A2GE Medical Systems China Co., Ltd.
2025-05-07Z-1637-2025Class IGE Healthcare CARESTATION 750c A1GE Medical Systems China Co., Ltd.
2025-05-07Z-1638-2025Class IGE Healthcare CARESTATION 750c A2GE Medical Systems China Co., Ltd.
2025-05-07Z-1661-2025Class IIThe Trimble RTS873 robotic total station is a solution designed for…Trimble Ab
2025-05-07Z-1672-2025Class IIDxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Inc.
2025-05-07Z-1673-2025Class IIStratus CS Acute Care cTNI TestPakSiemens Healthcare Diagnostics Inc
2025-05-07Z-1674-2025Class IIHyperthermia Pump Procedure KitBelmont Instrument LLC
2025-05-07Z-1675-2025Class IIStraight Inflow/Outflow Patient Line KitBelmont Instrument LLC
2025-05-07Z-1676-2025Class IIStraight Inflow/Bifurcated Outflow Line KitBelmont Instrument LLC
2025-05-07Z-1678-2025Class II3Belmont Instrument LLC
2025-05-07Z-1683-2025Class IIHistoCore PELORIS 3Leica Biosystems Melbourne Pty Ltd
2025-05-07Z-1684-2025Class IIepoc BGEM BUN Test CardSiemens Healthcare Diagnostics Inc
2025-05-07Z-1685-2025Class IIepoc BGEM Crea Test CardSiemens Healthcare Diagnostics Inc
2025-05-07Z-1686-2025Class IIIceSeed 1Boston Scientific Corporation
2025-05-07Z-1687-2025Class IIIceSeed 1Boston Scientific Corporation
2025-05-07Z-1688-2025Class IIIceSeed 1Boston Scientific Corporation
2025-05-07Z-1689-2025Class IIIceSeed 1Boston Scientific Corporation
2025-05-07Z-1690-2025Class IISemi-Automated External DefibrillatorsDefibtech, LLC
2025-05-07Z-1691-2025Class IIAutomated External DefibrillatorsDefibtech, LLC
2025-05-07Z-1692-2025Class IIAutomated External DefibrillatorsDefibtech, LLC
2025-05-07Z-1693-2025Class IIAutomated External DefibrillatorsDefibtech, LLC
2025-05-07Z-1694-2025Class IIAutomated External DefibrillatorsDefibtech, LLC
2025-05-07Z-1695-2025Class IIBrand Name: Quantum InformaticsSpectrum Medical Ltd.
2025-05-07Z-1696-2025Class IIBrand Name: Quantum InformaticsSpectrum Medical Ltd.
2025-05-07Z-1699-2025Class IIDistal Femoral AugmentWaldemar Link GmbH & Co. KG (Mfg Site)
2025-05-07Z-1700-2025Class IIPosterior Femoral AugmentWaldemar Link GmbH & Co. KG (Mfg Site)
2025-05-07Z-1701-2025Class IIL-Shaped Femoral AugmentWaldemar Link GmbH & Co. KG (Mfg Site)
2025-05-07Z-1702-2025Class IITibial AugmentWaldemar Link GmbH & Co. KG (Mfg Site)
2025-05-07Z-1703-2025Class IImyQA iONIBA Dosimetry GmbH
2025-05-07Z-1704-2025Class IIEnhanced Verify Evaluation HandsetMedtronic Neuromodulation
2025-05-07Z-1705-2025Class IIMedline Sterile WaterMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1706-2025Class IIMedline Sterile 0MEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1707-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1708-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1709-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1710-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1711-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1712-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1713-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1714-2025Class IIMedline procedure kitsMEDLINE INDUSTRIES, LP - Northfield
2025-05-07Z-1715-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE…Olympus Corporation of the Americas
2025-04-30Z-1580-2025Class IIZenition 50Philips North America Llc
2025-04-30Z-1581-2025Class IIZenition 70Philips North America Llc
2025-04-30Z-1582-2025Class IIVeradius UnityPhilips North America Llc
2025-04-30Z-1583-2025Class IIZenition 70Philips Medical Systems Nederland B.V.
2025-04-30Z-1585-2025Class IBrand Name: Novasight Hybrid System Product Name: Novasight Hybrid…Conavi Medical Inc.
2025-04-30Z-1622-2025Class IIThe VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is…Maquet Cardiovascular, LLC
2025-04-30Z-1623-2025Class IINIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4Medtronic Xomed, Inc.
2025-04-30Z-1639-2025Class IIBD PYXIS MEDBANKCareFusion 303, Inc.
2025-04-30Z-1640-2025Class IIMerit MedicalMerit Medical Systems, Inc.
2025-04-30Z-1641-2025Class IIMerit MedicalMerit Medical Systems, Inc.
2025-04-30Z-1643-2025Class IIAmplatzer TorqVue LP Delivery SystemAbbott
2025-04-30Z-1644-2025Class IIAmplatzer TorqVue LP CatheterAbbott
2025-04-30Z-1645-2025Class IIZimmer Biomet Ceramic HeadZimmer, Inc.
2025-04-30Z-1646-2025Class IIZimmer Biomet Ceramic HeadZimmer, Inc.
2025-04-30Z-1647-2025Class IIZimmer Biomet Ceramic HeadZimmer, Inc.
2025-04-30Z-1648-2025Class IIZimmer Biomet Ceramic HeadZimmer, Inc.
2025-04-30Z-1649-2025Class IIZimmer Biomet Ceramic HeadZimmer, Inc.
2025-04-30Z-1650-2025Class IIInPen smart insulin penMedtronic MiniMed, Inc.
2025-04-30Z-1651-2025Class IIstryker Latitude EV HUMERAL REVISION STEM TRIALTornier, Inc
2025-04-30Z-1652-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Abbott Laboratories
2025-04-30Z-1653-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Abbott Laboratories
2025-04-30Z-1654-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Abbott Laboratories
2025-04-30Z-1655-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Abbott Laboratories
2025-04-30Z-1656-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Abbott Laboratories
2025-04-30Z-1657-2025Class IIMAGEC 2 RodGlobus Medical, Inc.
2025-04-30Z-1658-2025Class IIEdge Biologicals STERILE WATEREdge Biologicals Inc
2025-04-30Z-1659-2025Class IIRadiometer ABL90 SeriesRadiometer Medical ApS
2025-04-30Z-1660-2025Class IIPhilips Brilliance CT Big BorePhilips North America Llc
2025-04-30Z-1663-2025Class IISkytron Freedom 4FXS-60 Heavy Duty Monitor MountIHB OPERATIONS B.V.
2025-04-30Z-1664-2025Class IIBeckman Coulter DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-04-30Z-1665-2025Class IIThe Alinity m System is designed to automate the steps for nucleic…Abbott Molecular, Inc.
2025-04-30Z-1666-2025Class IITempus Pro Patient MonitorRemote Diagnostic Technologies Ltd.
2025-04-30Z-1669-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog…Micro-X Ltd.
2025-04-30Z-1670-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog…Micro-X Ltd.
2025-04-30Z-1671-2025Class IIWB XL Anatomic Healing Abutment XCStraumann USA LLC
2025-04-23Z-1507-2025Class IBD 4 Fr Single-Lumen PowerPICC CathetersBard Access Systems, Inc.
2025-04-23Z-1519-2025Class It:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.
2025-04-23Z-1520-2025Class ITandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.

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