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 Abbott Infinity 5, Implantable Pulse Generator Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Abbott Infinity 7, Implantable Pulse Generator Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Abbott Infinity 7, Implantable Pulse Generator Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be… If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas and Virginia named
- Medical device recall Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas and Virginia named
- Medical device recall Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing… If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas and Virginia named
- Medical device recall Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool… If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas and Virginia named
- Medical device recall LINK SymphoKnee Patella Sizing Template The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Kansas, Ohio and Wisconsin named
- Medical device recall Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003) Nine (9) Impella CP pumps failed inspection and were inadvertently released. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 24, 2024ClassClass IStatusOngoingWhereFlorida, Massachusetts, Ohio and Texas
- Medical device recall Volara System Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Volara System Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 One lot of product has dilators that are too short and will not extend outside the introducer sheath. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cascade IOMAX Cortical Module Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereCalifornia and Illinois
- Medical device recall Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170 Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Multitest 6-Color TBNK CE-IVD Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic… Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and… The tiller separates from the base/front caster assembly. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and… The tiller separates from the base/front caster assembly. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mi1250 SYNCHRONY 2 A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNorth Carolina
- Medical device recall Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, Nevada, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Washington
- Medical device recall Abbott Proclaim XR 5 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim 5 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim XR 7 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim 7 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim 5 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim 7 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim Plus 5 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim Plus 5 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim Plus 7 Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Abbott Proclaim DRG Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim 7 Elite Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proclaim 5 Elite Implantable Pulse Generator The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 24, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall UNITRAX Endoprosthesis Head Component - 43mm Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UNITRAX Endoprosthesis Head Component - 42mm Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UNITRAX Endoprosthesis Head Component - 38mm Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI,… Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis: MedStation ES (Main) If automated dispensing cabinets have specific software versions, and Component Manager was configured to “installed mode”, and software patch KB 5033688 was… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV)… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV)… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 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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