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 FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro… FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Hawaii, Iowa, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Extractor Pro RX Retrieval Balloon Catheter The product in incorrectly labeled. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Idaho, Illinois, Indiana, Massachusetts, Maine, Michigan, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall Juggerknot Mini Soft Anchors The outer carton box label is for the JuggerKnot 1.0mm Mini products. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Chromophare Surgical Light System Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, Illinois, Minnesota, New York, Oregon, Texas, Utah and Vermont named
- Medical device recall t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BeneVision N1 Patient Monitor (N1) Potential for activation of an abnormal alarm pause. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 OR Table Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 OR Table Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane OR Table Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 OR Table Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/10 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 OR Table Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979,… Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Reports of out-of-box failures discovered during the limited launch phase. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Maryland and Texas named
- Medical device recall 3M Ranger Blood/Fluid Warming High Flow Set Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 24, 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 a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 24, 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 a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 24, 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 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, 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 and West Virginia named
- Medical device recall Chemistry Products LAC Slides VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Chemistry Products LAC Slides VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe, Reverse Shoulder Humeral Liners Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Their is the potential for weak staining which may result in false negative CD20 identification. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Their is the potential for weak staining which may result in false negative CD20 identification. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Their is the potential for weak staining which may result in false negative CD20 identification. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN) Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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 and West Virginia named
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a… The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC)… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC)… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029,… Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC)… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC)… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall Frontier Devices Labeling includes shelf life that has not been validated. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas named
- Medical device recall i-STAT CG4+ cartridge (white) Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall i-STAT CG8+ cartridge Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.