Medical devices
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2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Philips Azurion systems not configured with an optional auxiliary pan handle Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Silastic Foley Catheters Silastic Brand Foley Catheter 30cc Due to stain present on the surface of affected foley catheters. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Azurion system The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura system The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Integris-Allura system The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in… Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rolls of label stock used with the Omnicell i.v.Station. 1 Potential for mislabeled syringe produced by the i.v.STATION device. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereAlabama, Maryland and Pennsylvania
- Medical device recall Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter… Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide, and Arizona named
- Medical device recall On-X Mitral Heart Valve with Conform-X Sewing Ring Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, containing Namic Manifold, Labeled as: 1 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU… Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall 1. 3 VALVE MAN KIT, Medline Kit Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit… Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, containing Namic Manifold, Labeled as: 1 Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU… Medline has identified the presence of particulate within the fluid path of the Manifolds. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Revolution Ascend, computed tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution CT, x-ray computed tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution Apex Elite, X-ray Computed Tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution Apex Plus, X-ray Computed Tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution CT ES, X-ray Computed Tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution Apex, X-ray Computed Tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revolution Apex Select, X-ray Computed Tomography GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow Edge Hemodialysis Catheterization Product 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cannon II Plus Hemodialysis Catheter 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall NextStep Antegrade Chronic Hemodialysis Catheter 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS… Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Nevada, Ohio, South Carolina, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall Diowave Laser System Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Florida, Maryland, Michigan, Minnesota, Pennsylvania and Texas named
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 20, 2026ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 20, 2026ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 20, 2026ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Thermedx FluidSmart Urology Tube Set Due to nonconforming products being inadvertently distributed. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3DIMENSIONS MAMMOGRAPHY SYSTEM Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QuickVue Dipstick Strep A Test, 50T Product has the potential for false positive results Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New York, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Philips Azurion Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Minnesota, Missouri, North Carolina, New Mexico, New York, Virginia, Washington and Wisconsin named
- Medical device recall Edwards EVOQUE tricuspid delivery system Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 Codman CerebroFlo EVD Catheter with Endexo Technology Out-of-specification endotoxin result that did not meet the acceptance criteria. Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Oregon, Texas and Washington named
- Medical device recall BARD Dynamic Deca Steerable, Product Number 201101 Incomplete seals on sterile product Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass 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.
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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