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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. Seal defects could compromise the ability of the product packaging to maintain sterility. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 10, 2024ClassClass IIStatusCompletedWhereNationwide, and Minnesota named
- Medical device recall SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM… A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL. Class IIIFDA’s classJan 10, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 10, 2024ClassClass IIIStatusOngoingWhereNew York and West Virginia
- Medical device recall Reverse Shoulder System e+ Mislabeling Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 10, 2024ClassClass IIStatusCompletedWhereNationwide, and Alabama, California, Florida, Indiana, Louisiana, Maine, Minnesota, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Mislabeling Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 10, 2024ClassClass IIStatusCompletedWhereNationwide, and Alabama, California, Florida, Indiana, Louisiana, Maine, Minnesota, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,… The sterility of microcatheter and infusion system devices cannot be guaranteed. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah and Wisconsin named
- Medical device recall Merit Pursue Microcatheter The sterility of microcatheter and infusion system devices cannot be guaranteed. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah and Wisconsin named
- Medical device recall Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY The sterility of microcatheter and infusion system devices cannot be guaranteed. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah and Wisconsin named
- Medical device recall KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as… Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Valleylab FT10, FT Series Energy Platform Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Conventional Knife Crescent 2.5mm, 55 degrees bevel up One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall External Drainage System Collection Bag Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EDS 3 CSF External Drainage System Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Impella Connect, software portal for online device management that allows clinicians and Impella support… The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness:… Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B… The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Vitality Polyaxial Screw, 7.5mmx 50mm Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size… Class IIFDA’s classJan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Minnesota and Nebraska named
- Medical device recall Tracheostomy care kits The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall (1) Nursing Skills kit The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall (1) Nurse Kit The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode Affected product codes are now limited to use in patients age 12 years or older. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return… Affected product codes are now limited to use in patients age 12 years or older. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return… Affected product codes are now limited to use in patients age 12 years or older. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return… Affected product codes are now limited to use in patients age 12 years or older. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with… Unintended movement of bed wheels Class IIFDA’s classJan 3, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, Nevada, New York, Pennsylvania, South Dakota and Tennessee
- Medical device recall Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with… Unintended movement of bed wheels Class IIFDA’s classJan 3, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, Nevada, New York, Pennsylvania, South Dakota and Tennessee
- Medical device recall Alinity ci-series System Control Module There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during… Class IIFDA’s classJan 3, 2024in FDA’s Enforcement Report46 statesnamed in where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, 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
- Medical device recall Medtronic SynchroMed II Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the… Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic SynchroMed II Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the… Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Landauer microSTARii reader, Medical Dosimetry System MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2024ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope… Identification label on affected hookups could become illegible over time due to the label’s ink coming off. Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE Due to potential breakage during use. Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Liberty Select Cycler Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. Class IIIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 3, 2024ClassClass IIIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Atrium Oasis Drain Single W / AC A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DeRoyal CARDIAC CATH SET-UP KIT PGYBK Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life… Class IIFDA’s classJan 3, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 3, 2024ClassClass IIStatusOngoingWhereVirginia
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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