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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Chest Drainage Units and Accessories The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evolution Upgrade 1.5T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Evolution Upgrade 3.0T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia 1.5T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia 3.0T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia 3.0T CX The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia Ambition S The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia Ambition X The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia Elition S The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Ingenia Elition X The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall Upgrade to MR 7700 The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall SmartPath to dStream for 3.0T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall SmartPath to dStream for XR and 3.0T The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall BD Alaris” Pump Module Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Indiana, Ohio and Virginia named
- Medical device recall Brand Name: LimFlow Vector Product Name: LimFlow Vector Incorrect expiration date Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Connecticut, District of Columbia, Florida, Kentucky, Massachusetts, Michigan, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Wyoming named
- Medical device recall LSL Healthcare, Central Line Dressing Kit BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Idaho named
- Medical device recall BEAR Implant Incorrect expiration date on label that extends beyond the product’s documented/approved shelf life. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Texas, Virginia, Washington and Wisconsin named
- Medical device recall MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 28, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 28, 2026ClassClass IStatusOngoingWhereCalifornia and Pennsylvania
- Medical device recall RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: RayStation Product Name: RayStation/RayPlan Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). Class IIFDA’s classJan 28, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 28, 2026ClassClass IIStatusOngoingWhereNo 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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