Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall FLIXENE, 7X50, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 6X40, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 7X40, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 7X80, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 6X30, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 7X30, 1GDS, GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 6X50, 1GDS, STR Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 7X50, 1GDS, STR Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 6X30, 1GDS, STR Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-6X35, 2GDS, GWT-GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-7X35, 2GDS, GWT-GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-6X45, 2GDS, GWT Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-7X45, 2GDS, GWT Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-6X45, 2GDS, GWT-GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-7X45, 2GDS, GWT-GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLIXENE, 4-7X30, 2GDS, GWT-GW Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GlideScope Core 15-inch Monitor Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement Report47 statesnamed in where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereAlaska, 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, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Brand Name: GlideScope Core 15-inch FHD Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement Report47 statesnamed in where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereAlaska, 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, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD SARS-CoV-2 Reagents for BD MAX” Systems Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE STERILE IRIS SCISSORS CVD/STD There is the potential of the tip protector to fall off 4.5” sterile, curved, Iris Scissors Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BSM-3000 Series Bedside Monitor Due to software issue the device may give false “SpO2 Probe Failure” alarm Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Iowa named
- Medical device recall O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and… Potential for an electrical component of the O-arm” O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Minnesota, Puerto Rico, Texas and Wisconsin named
- Medical device recall GE HealthCare CRITIKON ONE-CUF blood pressure cuffs Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Philips Tempus LS-Manual Defibrillator Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which… Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OES 4000 Hysteroscope The required leakage test was not performed following of a re-work for a non-conformity. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall Medline Sub-G Endotracheal Tube with Subglottic Suctioning Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and… Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Captus 4000e Thyroid Uptake System Complaints of unexpected detachment of the collimator have been reported. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Captus 4000e Thyroid Uptake System with Well Complaints of unexpected detachment of the collimator have been reported. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Captus 4000e Thyroid Uptake System with Well and 2 inch shielding Complaints of unexpected detachment of the collimator have been reported. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura Xper FD20 system with an ADN7NT patient table When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJun 5, 2024ClassClass IIStatusOngoingWhereOklahoma
- Medical device recall Philips Allura Xper FD10 system with an ADN7NT patient table When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJun 5, 2024ClassClass IIStatusOngoingWhereOklahoma
- Medical device recall Philips Allura Xper FD20 Biplane system with an ADN7NT patient table When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJun 5, 2024ClassClass IIStatusOngoingWhereOklahoma
- Medical device recall FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal… Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Florida, Illinois, Nebraska, New Hampshire, Ohio, Tennessee and Wisconsin named
- Medical device recall Brand Name: EsophaCap Product Name: EsophaCap The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Maryland and Minnesota named
- Medical device recall Brand Name: EsophaCap Product Name: EsophaCap The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Maryland and Minnesota named
- Medical device recall smith&nephew OXINIUM Femoral Head 12/14 Taper Packaging contained the incorrect size of femoral head from what was displayed on the label. Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Trevo XP ProVue Retriever 4 x 20 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Trevo ProVue Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Trevo Pro 14 Microcatheter Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Trevo NXT ProVue 3 x 32, US Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Trevo Trak 21 Microcatheter Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall FlowGate2 8F x 85cm Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall DAC 044 115cm Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Synchro .014”guide wire, 35 cm tip Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total… Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3… Class IIFDA’s classJun 5, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2024ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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