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 Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits IHDC30R D AND C PACK Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL,… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated… IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96” IV sets may leak. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall Product: STA Liatest D-Di A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NOxBOXi Nitric Oxide Delivery System Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2025in FDA’s Enforcement ReportTennesseethe one state its words name PublishedOct 15, 2025ClassClass IStatusOngoingWhereTennessee
- Medical device recall NOxBOXi Nitric Oxide Delivery System The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2025in FDA’s Enforcement ReportTennesseethe one state its words name PublishedOct 15, 2025ClassClass IStatusOngoingWhereTennessee
- Medical device recall BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter,… Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography… It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ClariTEE Miniaturized TEE probe Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, New Jersey, Pennsylvania and South Carolina named
- Medical device recall CorNeat EverPatch Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm… Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Optiflux¿ High Flux E-beam Dialyzer To provide further information to the user to ensure proper use of the medical device. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FDR Visionary Suite, CH-200 It was found that the shaft for mounting the X-ray tube unit on the support may break. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report8 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereAlaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio and Wisconsin
- Medical device recall AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Firm has identified a security vulnerability in AW Server products. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with… Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall SYNCHRON Systems Phosphorus (PHOSm) Reagent Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereAlabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington and West Virginia
- Medical device recall Artegraft Collagen Vascular Graft Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall FlexLab (FLX) System The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereCalifornia and New York
- Medical device recall FlexLab X (FXX) System The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereCalifornia and New York
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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