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 American Contract Systems Gyn Laparoscopy convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole… Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Special Procedure Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and… Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Cataract Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Biopsy Drape Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall American Contract Systems Spine Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Maine, Minnesota, Missouri, Nebraska and South Dakota named
- Medical device recall Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible… The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible… The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible… The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica HistoCore Arcadia H An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump Improperly performed testing prior to release Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared… Grafts were found to have been approved, released, shipped and implanted with an invalid test results. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Florida and New York named
- Medical device recall (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized… Grafts were found to have been approved, released, shipped and implanted with an invalid test results. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Florida and New York named
- Medical device recall Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, Nevada, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2-… Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NavaClick Syringe and Needle Incorrect GTIN number on carton. Class IIIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2024ClassClass IIIStatusOngoingWhereNationwide, and Michigan and South Carolina named
- Medical device recall Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage… IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an… IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an… IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD… IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on… Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on… Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on… Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SlideView VS200 slide viewer A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260 Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250 Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis Mislabeled. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis Mislabeled. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxC 500 AU Clinical Chemistry Analyzer There are two software bug issues with the analyzer. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia, Hawaii, Illinois, Michigan, Minnesota, Mississippi, Nebraska, New York, Oregon, Pennsylvania and South Carolina named
- Medical device recall BIOFIRE Blood Culture Identification 2 (BCID2) Panel If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may… Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00 If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient… Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 7, 2024ClassClass IIStatusOngoingWhereIllinois
- Medical device recall NIM Vital Nerve Monitoring systems (all serial numbers Potential for false negative response on the NIM Vital Nerve Monitoring System FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Dxl 9000 Access Immunoassay Analyzer The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Indiana, Kansas, New Hampshire, Pennsylvania and Texas named
- Medical device recall ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and… Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arial Call Station There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereCalifornia, Maryland, Minnesota, Mississippi, Nebraska, Oregon, Texas, Washington and Wisconsin
- Medical device recall Arial Call Station This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereAlabama, California, Florida, Maryland, Minnesota, Mississippi, North Dakota, Nebraska, New York, Oregon, Texas, Washington and Wisconsin
- Medical device recall MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TourniKwik Tourniquet Set (CFN 79012) Incorrect component placed in four manufactured lots of the TourniKwik” Tourniquet Set. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota and Utah named
- Medical device recall BD Nano 2nd Gen Pen Needles 32G X 4mm BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on… Cystatin C Reagent marketed without a 510 (k) Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia and New York named
- Medical device recall ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: “ In Vitro testing… Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and 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 Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as… Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- 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
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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