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 DASH SARS-CoV-2 & Flu A/B Test Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereFlorida, New York, Texas and West Virginia
- Medical device recall One-piece Guedel airway, size 2, ISO 8.0, green Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation,… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah and Virginia
- Medical device recall One-piece Guedel airway, size 3, ISO 9.0, yellow Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation,… Class IIFDA’s classAug 13, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah and Virginia
- Medical device recall Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135 Tourniquet cuff flange may become detached from the bladder. Class IIFDA’s classAug 13, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Molding Equipment Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SafeStar 90 Plus Filter Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall SafeStar 55 Plus Filter Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall HME TwinStar HEPA Plus Filter Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall SafeStar 60A Plus Filter Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1 A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 6, 2025ClassClass IStatusOngoingWhereNationwide, and Arizona, Colorado, Connecticut, Georgia, Illinois, Indiana, Massachusetts, Maine, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify… The Drill stop kit contains incorrect components. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Louisiana, Maryland, New Jersey, Nevada, New York, Ohio, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access… Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Inseego USB8 4G Dongle Kit Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Kentucky, Michigan, Nevada and South Carolina named
- Medical device recall Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems The DFPM yoke assembly (“yoke assembly”) may detach from the spring arm. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems The DFPM yoke assembly (“yoke assembly”) may detach from the spring arm. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Allura R8.2.x Systems Potential for temporary loss of imaging (X-ray) functionality due to software issue. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BostonSight SCLERAL Lens Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusCompletedWhereNationwide
- Medical device recall BostonSight PROSE Lens. Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Phasor Drill Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Delaware, Florida, Georgia, Guam, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Sprinter Cart/Sprinter Cart XL Infusion Pole Device does not comply with the labeling requirements of international standard IEC 60601-1. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LYFO-DISK, M KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK” 0894L may result in failure to recover the target microorganism. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LYFO-DISK, M KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK” 0894L may result in failure to recover the target microorganism. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IontoPatch STAT, On-the-Go Patch Therapy The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois, Indiana, Kentucky, Minnesota, New Jersey, New York, Ohio, South Dakota and Tennessee named
- Medical device recall IontoPatch 80, On-the-Go Patch Therapy The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois, Indiana, Kentucky, Minnesota, New Jersey, New York, Ohio, South Dakota and Tennessee named
- Medical device recall Precision Sampling Set Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Massachusetts, Pennsylvania, Texas and Utah named
- Medical device recall SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253 The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution Upgrade 1.5T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution Upgrade 3.0T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T S The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T CX The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition X The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition S The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Elition X The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 3.0T Quasar Dual The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152 The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR 7700 Model Numbers (REF): (1) 782120, (2) 782153 The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for 3.0T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartPath to Ingenia Elition X The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Upgrade to MR 7700 The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital… Devices had an unapproved slabbing software function enabled for use. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 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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