Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Product Name: Ingenia 1.5T S Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia 3.0T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia Ambition S Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia 1.5T CX Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia 3.0T CX Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia Ambition X Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia Elition S Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia Elition X Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MR 5300 Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MR 7700 Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Tennessee, Texas and Washington named
- Medical device recall TRUE 3D VIEWER SYSTEM Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, New Jersey, Ohio and Pennsylvania named
- Medical device recall BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall PhenoMATRIX AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Illinois, Kansas, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Pennsylvania, Texas and Utah named
- Medical device recall HiResolution” Bionic Ear System - M Battery Charger Due to incorrect the battery charger being packaged and distributed. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Michigan, South Carolina, Tennessee and Texas
- Medical device recall Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Adapters may disconnect during setup or while in use, potentially interrupting ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Adapters may disconnect during setup or while in use, potentially interrupting ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Welch Allyn Life2000 Ventilation system A cybersecurity vulnerability was discovered through internal testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 21, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Life2000 Compressor A cybersecurity vulnerability was discovered through internal testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 21, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MedicaLyte Liquid Bicarbonate Concentrate Potential for the presence of visible foreign matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 21, 2025ClassClass IStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall Halyard CHRIST SUTURE KIT An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois and Louisiana named
- Medical device recall Halyard SUTURE PACK CABG An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois and Louisiana named
- Medical device recall Halyard RAPIDES E-PACK An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois and Louisiana named
- Medical device recall Brand Name: Contour Product Name: Contour Gold Eyelid Weight Due to mislabeling of products Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maine, Michigan, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas and West Virginia named
- Medical device recall Brand Name: Contour Product Name: Contour Gold Eyelid Weight Due to mislabeling of products Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maine, Michigan, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas and West Virginia named
- Medical device recall FoundationOne Companion Diagnostic (F1CDx) Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia and New York named
- Medical device recall Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse… There were reports of an increase in reactive negative controls and false positive results. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT)… There were reports of an increase in reactive negative controls and false positive results. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TufTex Over-the-Wire Embolectomy Catheter During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pruitt Occlusion Catheter During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pruitt Irrigation Occlusion Catheter During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device… The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 21, 2025ClassClass IIStatusOngoingWhereGeorgia
- Medical device recall BIB Balloon in Balloon Dilatation Catheter Balloon extension lumens are not printed correctly. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 21, 2025ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Augmedics Perc Pin Adaptor The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous… Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Mississippi, New York, Pennsylvania, Tennessee and Virginia named
- Medical device recall CMS8000 Patient Monitor Patient monitor has nine identified cybersecurity vulnerabilities. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kentucky and Texas named
- Medical device recall Centurion Sterile Weitlaner Retractor, Reorder: 67315 Three is the potential for the retractors to puncture through the sterile packaging. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 Three is the potential for the retractors to puncture through the sterile packaging. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical… Potential for microbial contamination. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall KliniTray Platte Faxitron ,groB “R” sterile Potential for microbial contamination. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Enterprise 1.5T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 0.5T Standard The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.0T Omni/Stellar The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.0T Power/Pulsar The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T, Model Numbers: 781195 and 781295 The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Explorer/Nova Dual The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass 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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