Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH,… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH,… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH… Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker CHROMOPHARE Softlit Ring Surgical Light System Surgical light assembly may not adequate support the weight of the ceiling cover. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Jiffy Original Composite Polisher Cups (Coarse) 12pk Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report31 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ENFIT G-TUBE CONNECTOR, MEDLINE Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing ENFIT G-TUBE CONNECTOR 1 Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vue Motion V12 Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Radiology Procedure Kits There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System… Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar… Due to increased complaints for broken/frayed grip cables for reusable instruments. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double… Due to increased complaints for broken/frayed grip cables for reusable instruments. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver… Due to increased complaints for broken/frayed grip cables for reusable instruments. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor… Due to increased complaints for broken/frayed grip cables for reusable instruments. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps… Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery… Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Potential for the balloon in the device to not meet burst specifications. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and New Jersey named
- Medical device recall Airway Exam Kit, DYKE1796 Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Medline convenience kits containing Olympus biopsy valves: 1 Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall THORACIC ROBOTS, DYNJ908777B Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Medline kits containing Olympus biopsy valves: 1 Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Medline kits containing Olympus biopsy valves: 1 Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Medline kits containing Olympus biopsy valves: 1 Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall MEDLINE ANTERIOR HIP PACK DYNJ64672B Kits contain recalled Olympus biopsy valves. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall eTRAX Needle System Starter Kit 12G (for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle System Starter Kit 14G (for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle System Starter Kit 16G(for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle System Starter Kit 18G (for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle Sensor - 12G (for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle Sensor - 14G(for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle Sensor - 16G(for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall eTRAX Needle Sensor - 18G (for Aurora Trackers) There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Washington
- Medical device recall MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 620G Insulin Pump (MMT-1750) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
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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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