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 Stryker, StrykeFlow Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 30, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Baxter SIGMA Spectrum Infusion Pump V6 Certain Spectrum infusion pumps may have an incorrect version of software. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 23, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 23, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma and Virginia
- Medical device recall Baxter SIGMA Spectrum Infusion Pump V8 Certain Spectrum infusion pumps may have an incorrect version of software. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 23, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 23, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma and Virginia
- Medical device recall i-view video laryngoscope Potential for faulty devices as a result of depleted batteries. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 23, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 23, 2025ClassClass IStatusOngoingWhereArizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Laser light show projectors The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Laser light show projectors The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Laser light show projectors The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NeuroSync EYE-SYNC containing Pico Neo 2 Headsets Eye syncing issues causing the device to be inoperable. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, New York and Texas named
- Medical device recall Access Vitamin B12 Reagent Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 23, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Missouri, Mississippi, New York, Tennessee, Texas and Virginia named
- Medical device recall Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Missouri, Mississippi, New York, Tennessee, Texas and Virginia named
- Medical device recall VITROS Chemistry Products CHE Slides Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Missouri, Mississippi, New York, Tennessee, Texas and Virginia named
- Medical device recall VITROS Chemistry Products CHE Slides (Japan) Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Missouri, Mississippi, New York, Tennessee, Texas and Virginia named
- Medical device recall KWIK-STIK and LYFO DISK, quality control kit for culture media Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereOhio and Utah
- Medical device recall Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereArizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia and Washington
- Medical device recall Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereArizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia and Washington
- Medical device recall Medtronic SmartLink Software loaded on SmartSync Patient Connector A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic SmartLink software loaded on CareLink SmartSync Device Manager A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Q-Link 13 component The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 16, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Hillrom LikoScale component The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 16, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using… It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 16, 2025ClassClass IStatusOngoingWhereNationwide, and 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, Washington, Wisconsin and West Virginia named
- Medical device recall TrueDent Clear, TDM 100 Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2025ClassClass IIIStatusCompletedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New York, Oklahoma, Oregon, Utah and Wisconsin named
- Medical device recall TrueDent Cyan, TDM 120 Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2025ClassClass IIIStatusCompletedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New York, Oklahoma, Oregon, Utah and Wisconsin named
- Medical device recall TrueDent Magenta, TDM130 Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2025ClassClass IIIStatusCompletedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New York, Oklahoma, Oregon, Utah and Wisconsin named
- Medical device recall TrueDent Yellow, TDM140 Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2025ClassClass IIIStatusCompletedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New York, Oklahoma, Oregon, Utah and Wisconsin named
- Medical device recall TrueDent White, TDM110 Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2025ClassClass IIIStatusCompletedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New York, Oklahoma, Oregon, Utah and Wisconsin named
- Medical device recall Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Due to labeling error. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportIndianathe one state its words name PublishedJul 16, 2025ClassClass IIStatusOngoingWhereIndiana
- Medical device recall Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird Product packaging contains the wrong part number and kit contents. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 16, 2025ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall O-arm O2 Imaging System A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide, and Indiana, Minnesota and Mississippi named
- Medical device recall VersaCross Access Solution (VXSK), Product Description and ID: VXSK Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VersaCross RF Wire (VXW) Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112… Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX… Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Preat, Astra EV-compatible 4.2mm Digital Analog Due to manufacturing error, digital analog rotational feature is 180 degrees off. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Kentucky, Maryland, Minnesota, New York, Oklahoma and Pennsylvania named
- Medical device recall Brand Name: Alcon Laboratories, Inc Due to the potential that some units within specific lots were damaged during the manufacturing process. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 16, 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, 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 Brand Name: Alcon Laboratories, Inc Due to the potential that some units within specific lots were damaged during the manufacturing process. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 16, 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, 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 Brand Name: Alcon Laboratories, Inc Due to the potential that some units within specific lots were damaged during the manufacturing process. Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 16, 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, 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
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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