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 The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with… Expired Products distributed to customers Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida and Michigan named
- Medical device recall Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and… Expired Products distributed to customers Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida and Michigan named
- Medical device recall This product is a single use sterile device that is used to direct the lesion to the targeted site Expired Products distributed to customers Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Florida and Michigan named
- Medical device recall BD Alaris System Manager Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer, C11137 Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Abbott Liberta RC, Implantable Pulse Generator Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Products FS Diluent Pack 3 VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, New York and Pennsylvania named
- Medical device recall IsoLoc Prostate Immobilization Treatment Balloon Device Kit A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Illinois, Missouri, Mississippi, New Jersey, New Mexico, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter Diagnostic electrophysiology (EP) catheters do not meet testing requirements. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Life2000 Ventilator Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Inspire Model 3028, IV Implantable Pulse Generator There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and… Potential for coils to heat up and harm patients (burn). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and… Potential for coils to heat up and harm patients (burn). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera… Potential for coils to heat up and harm patients (burn). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation,… Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CARESCAPE Canvas 1000 GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CARESCAPE Canvas Smart Display GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CARESCAPE Canvas Smart Display GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CARESCAPE B650 GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CARESCAPE B850 GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Sight OLO CBC Test Kit One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Mississippi, Texas and Wisconsin named
- Medical device recall Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the… The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1 Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm… Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when… Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Scaler Tip - Perio Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Blis-Sonic Scaler Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, New Jersey, Pennsylvania, Texas and Virginia named
- Medical device recall AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for… Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall COBALT HF QUAD CRT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT XT HF CRT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall Cobalt XT HF CDT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT XT HF QUAD CRT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall COBALT XT HF QUAD CRT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall CROME HF QUAD CRT-D MRI SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall EVERA MRI S VR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall EVERA MRI S DR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia named
- Medical device recall EVERA MRI S DR SureScan Potential for manufacturing defect. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas and Virginia 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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