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 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013… Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Dexcom One+ Continuous Glucose Monitoring System Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013… Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall AcoSound. Model Number: LW12-BTE-M Three issues 1. Class IIIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2025ClassClass IIIStatusOngoingWhereNationwide, and New York named
- Medical device recall REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be… Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Devices were distributed in the U.S. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Devices were distributed in the U.S. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to… Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Kentucky, Minnesota, Mississippi, North Dakota, Nevada and Virginia named
- Medical device recall UROSKOP Omnia A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UROSKOP Omnia Max A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet Potential presence of residual adhesive material on the mesh surface. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 25, 2025ClassClass IIStatusCompletedWhereCalifornia, Illinois and Nebraska
- Medical device recall SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier Potential presence of residual adhesive material on the mesh surface. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 25, 2025ClassClass IIStatusCompletedWhereCalifornia, Illinois and Nebraska
- Medical device recall SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh Potential presence of residual adhesive material on the mesh surface. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 25, 2025ClassClass IIStatusCompletedWhereCalifornia, Illinois and Nebraska
- Medical device recall SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet Potential presence of residual adhesive material on the mesh surface. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 25, 2025ClassClass IIStatusCompletedWhereCalifornia, Illinois and Nebraska
- Medical device recall Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter… Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas and Washington named
- Medical device recall Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK… Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663… Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall ICU Medical Plum Duo Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Iowa, Kentucky, Massachusetts, Mississippi, New York, Pennsylvania and Virginia named
- Medical device recall ICU Medical Plum Solos Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Iowa, Kentucky, Massachusetts, Mississippi, New York, Pennsylvania and Virginia named
- Medical device recall 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF… Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD),… Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall STA - Owren Koller Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% Class IIFDA’s classJun 25, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereGuam and Puerto Rico
- Medical device recall OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the… OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OEC 3D OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Z-800 Infusion System Unreleased software versions were installed on distributed devices without verification or validation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Z-800F Infusion System Unreleased software versions were installed on distributed devices without verification or validation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Z-800W Infusion System Unreleased software versions were installed on distributed devices without verification or validation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Z-800WF Infusion System Unreleased software versions were installed on distributed devices without verification or validation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter,… Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 18, 2025ClassClass IStatusOngoingWhereCalifornia, Colorado, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, New Jersey and Oregon named
- Medical device recall Newport HT70 Ventilator Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJun 18, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall LOWER EXTREMITY Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits,… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall SCD Comfort Knee Length Small Incorrect software logic may cause frequent E1 errors (system high pressure). Class IIFDA’s classJun 18, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 18, 2025ClassClass IIStatusCompletedWhereAlaska, California, Florida, Massachusetts and Texas
- Medical device recall Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow Incorrect software logic may cause frequent E1 errors (system high pressure). Class IIFDA’s classJun 18, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 18, 2025ClassClass IIStatusCompletedWhereAlaska, California, Florida, Massachusetts and Texas
- Medical device recall Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow Incorrect software logic may cause frequent E1 errors (system high pressure). Class IIFDA’s classJun 18, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 18, 2025ClassClass IIStatusCompletedWhereAlaska, California, Florida, Massachusetts and Texas
- Medical device recall Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azure S DR MRI SureScan, Product number W3DR01 Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition… Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall DxI 9000 Access Immunoassay Analyzer A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic… Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana and Texas named
- Medical device recall Achieva XR Product Numbers identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera 1.5T Achieva IT Nova Product Number: 781175 identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera 1.5T Achieva Nova Product Number: 781172 identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera 1.5T Achieva Nova-Dual Product Number: 781173 identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera 1.5T Explorer/Nova Dual Product Number: 781108 identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera 1.5T Master/Nova Product Number: 781106 identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota 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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