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 i-STAT EG7+ cartridge Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall i-STAT EG6+ cartridge Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heartstring III Proximal Seal System Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heartstring III Proximal Seal System, 3.8 MM Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heartstring III Proximal Seal System, 4.3 MM Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SureStep Foley Tray System Bardex I.C Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it’s natural rubber latex, or 2)Natural rubber latex with infection control… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall SureStep Foley Tray System Lubri-Sil I.C Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it’s natural rubber latex, or 2)Natural rubber latex with infection control… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it’s natural rubber latex, or 2)Natural rubber latex with infection control… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC,… Two new potential laser safety failure modes have been identified in the product design. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ViziShot 2FLEX Potential for undetected, deformed a-traumatic tips. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Artis Pheno. Image-Intensified Flouroscopic X-Ray System. Limited system movements after startup . Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Florida, Kentucky, Massachusetts, Michigan, New York, Oregon, Tennessee, Texas and Utah named
- Medical device recall Halyard, ENT PACK Potential for open header bag seals, compromising sterility. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Halyard, CPT BASIC IR PACK Potential for open header bag seals, compromising sterility. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device,… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Michigan, Missouri, New Jersey, New York, Oregon, Rhode Island, South Carolina, Tennessee and Texas named
- Medical device recall Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1 The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1 The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Boston Scientific NephroMax Kit, Material Numbers (UPN): 1 The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1 The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CorNeat EverPatch Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Indiana, New Jersey and Texas named
- Medical device recall Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliSpace Cardiovascular, Software 8.0.0.4. Software issue that results in the display of outdated information. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, North Carolina and Texas named
- Medical device recall NOxBOXi Nitric Oxide Delivery System Replacement of the internal Sample Pump due to high failure rates. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall QuickVue: Dipstick Strep A Test: 50T Dipstick strep A test has potential for false positive results. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD The reamer may kick or bind up during or immediately prior to use. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm The reamer may kick or bind up during or immediately prior to use. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE The reamer may kick or bind up during or immediately prior to use. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray The reamer may kick or bind up during or immediately prior to use. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000,… Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Measles IgM Test Kit lacks premarket approval or clearance. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, Texas and Utah named
- Medical device recall 10Fore Hemostasis Valve Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Louisiana, Montana, New York, South Dakota and Wisconsin named
- Medical device recall Reef TA Inserter Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Connecticut, Florida, Idaho, Michigan, Minnesota, North Carolina, Nevada, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas and Washington named
- Medical device recall PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Colorado named
- Medical device recall TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60… Failure of fusion system instruments in the field. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, New Jersey, Nevada, Oklahoma and Washington named
- Medical device recall TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45… Failure of fusion system instruments in the field. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, New Jersey, Nevada, Oklahoma and Washington named
- Medical device recall Novum IQ LVP (Large Volume Pump) Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 10, 2025ClassClass IStatusOngoingWherePuerto Rico
- Medical device recall Novum IQ Syringe Pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 10, 2025ClassClass IStatusOngoingWherePuerto Rico
- Medical device recall Novum IQ Syringe Pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 10, 2025ClassClass IStatusOngoingWherePuerto Rico
- Medical device recall WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040 Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNo state 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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