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 SmartPath to dStream for 1.5T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 7, 2024ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Michigan, Minnesota, Ohio and Washington named
- Medical device recall Atlan, Gas Machine for Anesthesia or Analgesia Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall NovoTHOR Whole Body Light Pod, Gen 3.0 One of the ball studs attaching a gas strut to the canopy may fail. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Maryland, New Jersey, New York, Oregon, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack Affected lots may experience increased calibration failures or an increase in falsely elevated results. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V The incorrect device is contained in the labeled package. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, North Carolina, Ohio, Tennessee and Virginia
- Medical device recall REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. Sterility of Ultrasound gel can not be guaranteed. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJan 31, 2024ClassClass IIStatusOngoingWhereIllinois
- Medical device recall Accure Laser System Laser system’s spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue,… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Louisiana, Massachusetts, Minnesota, New Jersey, New York, Ohio and Texas
- Medical device recall Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Model A710 Intellis Clinician Programmer Application, version 2.0.97 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Sedecal X Optima URS digital mobile diagnostic x-ray system Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereAlabama, Florida and North Carolina
- Medical device recall PANTHER FUSION System Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin and West Virginia named
- Medical device recall EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000 Complaints that specific samples produced false positive EliA GBM results. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter DxU 850m/840m Microscopy Analyzers Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall iQ200 Series Urine Microscopy Analyzers Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall REV 2 Flowcell Capsule Spare Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall iQ Waste Well Adapter Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 Knee batteries may need replacement with conforming batteries to ensure there isn’t a failure to turn on the device, or an unexpected shutdown, which is a… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Snapshot NIR Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Iowa, Illinois, Indiana, Missouri, Ohio, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ PreVent¿ Anti-Reflux Filter with ENFit BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit”, 12Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Lopez Valve¿ with ENFit BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard¿ Suction Connector with ENFit BD (C.R. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Achieva 1.5T An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas named
- Medical device recall Achieva 1.5T Conversion An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas named
- Medical device recall Achieva 3.0T An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas named
- Medical device recall Ingenia Ambition X An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas 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.”
Your shortlist0 of 4
Add one more to compare.