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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Nevada and Texas named
- Medical device recall Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Nevada and Texas named
- Medical device recall Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Nevada and Texas named
- Medical device recall remel BLOOD AGAR MacCONKEY AGAR BIPLATE Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging,… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall remel BLOOD AGAR EMB AGAR BIPLATE Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging,… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, New Hampshire, New Jersey, Ohio, Pennsylvania, Puerto Rico, South Carolina and Texas named
- Medical device recall Dexcom G6, Continuous Glucose Monitoring System Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, New Hampshire, New Jersey, Ohio, Pennsylvania, Puerto Rico, South Carolina and Texas named
- Medical device recall Dexcom G6, Continuous Glucose Monitoring System Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, New Hampshire, New Jersey, Ohio, Pennsylvania, Puerto Rico, South Carolina and Texas named
- Medical device recall Olympus Single Use Guide Sheath Kits with the following product descriptions and Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Vaporizer Sevoflurane, Quik-Fil Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 19, 2025ClassClass IStatusOngoingWhereConnecticut and Kentucky
- Medical device recall The MSOT Acuity Echo is a Class 4 medical laser device The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2025ClassClass IStatusOngoingWhereAlaska, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2025ClassClass IStatusOngoingWhereAlaska, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall (1) Pyxis MedStation ES Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3)… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) BD Pyxis MedStation ES Labeling is insufficient regarding delays in access to medication. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MicoVention Terumo, LVIS Intraluminal Support Device Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BD Pyxis MedStation ES (Med ES Main) Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation Auxiliary ES Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation Auxiliary 4000 Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation 4000 Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT,DIEP FLAP Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1 Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1 Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) ACDF PACK Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker Precision Thin Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall stryker Precision Thin Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: The Guardian System Product Name: The Guardian Device reaching End of Service prematurely. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Indiana, Louisiana, Nevada, Oklahoma, South Carolina and Texas named
- Medical device recall Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600 Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause… Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement Report50 statesnamed in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 MOSAIQ Oncology Information System Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereAlabama, Florida, Iowa, Pennsylvania and Utah
- Medical device recall Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet) Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet) Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AcuMatch XLE Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas and Virginia
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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