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 Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TriMed, Threaded IM Nail 3.6mm, 60mm, TI Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall TriMed, Threaded IM Nail 3.6mm, 60mm, TI Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Medtronic Arterial Cannulae Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Clearview Blower/Mister Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic DLP Coronary Ostial Cannulae Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic I.M.A Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Tourniquet Sets: a) DLP¿ 5.5 in Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Venous Cannulae: a) DLP¿ 20 Fr Potential for unsealed sterile packing. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT Products have a lack of sterility assurance. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Kentucky, Mississippi, North Carolina, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Namic FLUID DELIVERY SET Products have a lack of sterility assurance. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Kentucky, Mississippi, North Carolina, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall WishFIX Growth Control Plating System The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereConnecticut, Florida and New Jersey
- Medical device recall LASER Application Instrument, 23 cm Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the… Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Nebraska, New York, Ohio, Texas and Wisconsin named
- Medical device recall Spectrum IQ Infusion pump There is a potential for cracks on the mount of the front panel of the device. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio and Wisconsin named
- Medical device recall VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free… T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the… Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use… Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
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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