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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNew York
- Medical device recall Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNew York
- Medical device recall Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction… A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Devices from the affected device lots have labels that state the incorrect expiration dates. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280… Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereFlorida and Nevada
- Medical device recall OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket Class IIFDA’s classNov 27, 2024in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereCalifornia, District of Columbia, Florida, Georgia, Massachusetts, New York, Ohio, Oklahoma, South Carolina, Texas and Virginia
- Medical device recall Z-800 Infusion System Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Trilogy Evo O2 Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B,… Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo Universal Ventilator Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy EV300 Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through… Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through… Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall LifeVent EVO2 Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device’s internal flow sensor, which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000 Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Brand Name: Atlan Product Name: Atlan A350 The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maine, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Wisconsin and Wyoming named
- Medical device recall Brand Name: Atlan Product Name: Atlan A350XL The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maine, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Wisconsin and Wyoming named
- Medical device recall Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall microTargeting Insertion Tube Set, P/N 66-IT-05P A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereArizona, California, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall SafeControl handset (a component of the Sentida bed which moves and positions the bed) When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall Imed Products Imed EVA BAG, 150 mL, 2-PORTS A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall Imed Products Imed EVA BAG, 250 mL, 2-PORTS A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall Imed Products Imed EVA BAG, 500 mL, 2-PORTS A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall Imed Products Imed EVA BAG, 1000 mL, 2-PORTS A limited number of IV bags have been found to leak during filling. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Texas, Utah and Washington named
- Medical device recall Approach CTO Micro Wire Guide, Guide Wire Affected device lots have labels that state the incorrect expiration dates. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Approach Hydro ST Micro Wire Guide Affected device lots have labels that state the incorrect expiration dates. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Spectrum IQ Infusion System with Dose IQ Safety Software The door on the Spectrum IQ Infusion pump may not be able to fully close. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereGeorgia and Idaho
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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