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 5, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Positron Emission Tomography and Computed Tomography System Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Brand Name: Performance Pro Product Name: Performance Pro Gloves may exhibit defects such as tears, missing fingers, and debris. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Opportunity Flex Product Name: Opportunity Flex Gloves may exhibit defects such as tears, missing fingers, and debris. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Opportunity Pro Product Name: Opportunity Pro Gloves may exhibit defects such as tears, missing fingers, and debris. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC… Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa, Minnesota, South Dakota and Wisconsin named
- Medical device recall Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC… Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa, Minnesota, South Dakota and Wisconsin named
- Medical device recall Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL… Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa, Minnesota, South Dakota and Wisconsin named
- Medical device recall Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE The kits contain tube sets with handpieces that may leak during use. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio and Texas named
- Medical device recall Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI The kits contain tube sets with handpieces that may leak during use. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio and Texas named
- Medical device recall Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN The kits contain tube sets with handpieces that may leak during use. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio and Texas named
- Medical device recall Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH The kits contain tube sets with handpieces that may leak during use. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio and Texas named
- Medical device recall Olympus M3 Gold Autoclavable Foroblique Telescope 30 There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus M3 Gold Autoclavable Lateral Telescope 70 There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PALACOS R pro 40 Potential for monomer liquid leakage. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PALACOS R+G pro 40 Potential for monomer liquid leakage. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PALACOS MV+G pro 40 Potential for monomer liquid leakage. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PALACOS MV pro 40 Potential for monomer liquid leakage. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Georgia named
- Medical device recall NOxBOXi Nitric Oxide Delivery System Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Ingenia Blue Seal SE and Blue Seal XE When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T, 1.5T CX, and 1.5T S When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T and 3.0T CX When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S and Ingenia Ambition X. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S and Ingenia Elition X. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13 When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13 When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and… When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to MR 7700 When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Upgrade dStream When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Upgrade to MR 7700 When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution upgrade 1.5T amd Evolution upgrade 3.0T When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall In-Line Valve, Product Number: P5-TEE Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Travel Air, Product Number: S00055 Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009 Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Pipeline Flex Embolization Device with Shield Technology Due to incorrect label/product dimensions. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia and Texas named
- Medical device recall Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Due to blood-to-glycol leak in the heat exchanger. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Due to blood-to-glycol leak in the heat exchanger. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Olympus Tripp-Lite P580-025 25ft DisplayPort Cable While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion… Due to manufacturing issues reperfusion catheters may fracture. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Louisiana, North Carolina, New York, Texas, Utah and Wisconsin named
- Medical device recall Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Minnesota, Missouri, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, South Dakota, Texas and Wisconsin named
- Medical device recall HOPKINS Telescope 30¿, 4mm Due to incorrect inside packaging label for eyepiece. Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California and Missouri named
- Medical device recall CHARLOTTE CLAW Screw Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads,… Class IIFDA’s classOct 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 7, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Idaho, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin 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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