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recall BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereArizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Aortic Root Cannula: 1 Unexpected loose material in the male luer used in the aortic root cannula has been identified. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Numerous models of nonsterile hemostatic forceps The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Numerous models of nonsterile hemostatic forceps The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Numerous models of nonsterile hemostatic forceps The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Numerous models of nonsterile hemostatic forceps The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Numerous models of nonsterile hemostatic forceps The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: TruScan Body Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately Class IIFDA’s classMar 19, 2025in FDA’s Enforcement Report16 statesnamed in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Minnesota, Mississippi, Ohio, Oregon, South Dakota, Utah, Virginia, Washington and Wisconsin
- Medical device recall COR Disposable Kit, 8 mm Device is missing the pin in the graft loader component. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall COR Disposable Kit, 8 mm w/ Perpendicularity Device is missing the pin in the graft loader component. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ZOLL Product Name: Powerheart G5 AED The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Spectral CT on Rails, Software Version Number 5.1.0 Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereMinnesota
- Medical device recall Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood,… Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Washington named
- Medical device recall Stryker CinchLock Flex Knotless Anchor with Inserter and Suture Increase in complaints concerning “pullwire” breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Z1 Femoral Hip System, Product Number 611777612 There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vista Brite Tip, Judkins Right 4 Catheter manufactured at the incorrect length. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereWashington
- Medical device recall VARIPULSE Bi-Directional Ablation Catheter Due to an observed trend of neurovascular events FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 12, 2025ClassClass IStatusTerminatedWhereArkansas, California, Colorado, Kansas, Louisiana, Massachusetts, Missouri, New York, Ohio and Texas
- Medical device recall Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 12, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medtronic Pipeline Vantage Embolization Device with Shield Technology Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 12, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medtronic Pipeline Vantage Embolization Device with Shield Technology Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 12, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Access Erythropoietin (EPO) Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement Report24 statesnamed in where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and West Virginia
- Medical device recall Brand Name: TBS Osteo Product Name: TBS iNsight Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement Report23 statesnamed in where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Washington
- Medical device recall human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm The cannula tubes do not comply with the specification. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Philips IntelliSpace Cardiovascular software Study data is not able to be archived, copied, or exported with the cardiovascular software version. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Baxter Sigma Spectrum Infusion System (V6 Platform) There is the potential for missing motor mounting screws, which may have occurred during the servicing process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter Spectrum IQ Infusion System with Dose IQ Safety Software There is the potential for missing motor mounting screws, which may have occurred during the servicing process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Paradigm REF: MMT-712 and MMT-715 All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Paradigm insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Paradigm insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed insulin pump All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 12, 2025ClassClass 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, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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.”
Your shortlist0 of 4
Add one more to compare.