Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Tego Connector Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal… Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare Omni Legend There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Philips Azurion system Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized… Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGMA Spectrum Infusion Pump Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mazor X robotic guidance system Software errors that can result in incorrect surgical instrument positioning during spinal surgery. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK… Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allwell Inflation Device, for angiographic use Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merit Medical , Custom Waste Management Kit Vascular Tray Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merit Medical , Custom Inflation Kit Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merit Medical , Custom Manifold Kit Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allwell Angioplasty Pack Inflation device handle may detach from the syringe during procedure. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL The console label for affected devices is missing the “DANGER” symbol. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 28, 2026ClassClass IIStatusCompletedWhereNationwide, and Texas named
- Medical device recall Brand Name: VOLT” Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate… The supplier manufactured anatomical left plates with an incorrect thread orientation. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: VOLT” Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate… The supplier manufactured anatomical left plates with an incorrect thread orientation. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Due to products not having FDA Premarket authorization to be distributed within the United States. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Missouri, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Due to probe bags that may have a compromised or incomplete sterile pouch seal. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement Report51 statesnamed in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The LDL-Cholesterol assay is comprised of two distinct phases Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement Report52 statesnamed in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, West Virginia and Wyoming
- Medical device recall TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes Under specific conditions, the lift’s electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rifton Equipment, TRAM Potential for fraying on the body support strap. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rifton Equipment, Low Base TRAM Potential for fraying on the body support strap. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rifton Equipment, E-Pacer Potential for fraying on the body support strap. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: EDAN Product Name: Fetal Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Fetal & Maternal Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Vital Signs Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Vital Signs Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Vital Signs Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Central Monitoring System As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Central Monitoring System As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Vital Signs Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Vital Signs Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Patient Monitor As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Brand Name: EDAN Product Name: Telemetry Transmitter As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Rhode Island and Texas named
- Medical device recall Patient Information Center iX A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SQ40S Blood Transfusion Filter Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. Class IIFDA’s classJan 28, 2026in FDA’s Enforcement Report28 statesnamed in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall VANTAGE GALAN 3T There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin named
- Medical device recall VANTAGE TITAN 3T There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin named
- Medical device recall FreeStyle Libre 3 Sensor Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2026in FDA’s Enforcement Report36 statesnamed in where it went PublishedJan 21, 2026ClassClass IStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall FreeStyle Libre 3 Plus Sensor Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2026in FDA’s Enforcement Report36 statesnamed in where it went PublishedJan 21, 2026ClassClass IStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall FreeStyle Libre 3 Plus Sensor Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 21, 2026in FDA’s Enforcement Report36 statesnamed in where it went PublishedJan 21, 2026ClassClass IStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
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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