Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Intera 1.5T Master/Nova The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Omni/Stellar The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Power/Pulsar The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T R11 The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 3.0T Quasar Dual The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera CV, Model Number: 781107 The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 3.0T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereAlabama, California, Georgia, Idaho, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Montana, North Carolina, Nevada, Pennsylvania, Puerto Rico, Tennessee, Texas and Wisconsin
- Medical device recall CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the… Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CADD-Solis HPCA Ambulatory Infusion Pump Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CADD-Solis VIP Ambulatory Infusion Pump Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Intraocular lens In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Intraocular Lens In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL… There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CODMAN Disposable Perforator, 14mm Inadequate weld that can potentially cause the product to disassemble. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm Inadequate weld that can potentially cause the product to disassemble. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 14, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Bio 1 Granules for Filling ¿ 1 mm Vials of implant bone granules may contain less product then specified on labeling. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits A single lot of the ImmunoCard STAT! Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Washer Disinfector Aquadis 56 The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in… Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Washer Disinfector Aquadis 56 The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in… Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Microstream Advance Neonatal-Infant Intubated CO2 Filter Line Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ambu aScope” 5 Broncho HD 5.6/2.8 Sampler Set Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Kentucky, Maryland, Montana, New Jersey, Nevada, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Montana, Oklahoma and Texas named
- Medical device recall Artix MT Thrombectomy Device Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which… Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, Florida, Georgia, Illinois, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Philips Tempus Pro Patient Monitor Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may… Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GALT Centeze Catheter Due to a potential open seal in the sterile barrier packaging . Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall B Braun Interventional Coaxial Dilator Due to a potential open seal in the sterile barrier packaging . Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall B Braun Interventional ELITE HV Hemostasis Valve Introducer System Due to a potential open seal in the sterile barrier packaging . Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall GALT Guidewire Due to a potential open seal in the sterile barrier packaging. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall Introducer Kit- Coaxial Dilator Due to a potential open seal in the sterile barrier packaging. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall Introducer Needle Due to a potential open seal in the sterile barrier packaging. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall Introducer Kit- Tearaway MicroSlide Due to a potential open seal in the sterile barrier packaging. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania and Utah named
- Medical device recall Blueprint Software, BPUE001 A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atalante X, Powered Exoskeleton Potential for exoskeleton to lose lateral balance and cause patient to fall. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNew York and Pennsylvania
- Medical device recall IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare CARESTATION 620 A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 620 A2 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Carestation 620 SE Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Carestation 620 A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 650 A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 650 A2 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Carestation 650 SE Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Carestation 650 A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 650C A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 650C A2 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Carestation 650c A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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