Medical devices
Shortlist up to four to read them side by side.
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 BARD Dynamic Tip Steerable, Product Number 200131 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
- Medical device recall BARD Dynamic Tip Steerable, Product Number 200344 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
- Medical device recall BARD Dynamic Tip Steerable, Product Number 6DYNTP001 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
- Medical device recall BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER 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
- Medical device recall BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER 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
- Medical device recall BARD Dynamic XT Steerable, Product Number 201104 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
- Medical device recall BARD EP XT Decapolar Steerable, Product Number 201007 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
- Medical device recall BARD EP XT Steerable, Product Number 200794 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
- Medical device recall BW Webster Duo-Decapolar, Product Number D728260RT 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
- Medical device recall CS Uni-Directional w Auto ID, Product Number D135303 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
- Medical device recall CS Uni-Directional w Auto ID, Product Number D135304 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
- Medical device recall Daig Livewire Steerable, Product Number 401575 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
- Medical device recall Daig Livewire Steerable, Product Number 401581 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
- Medical device recall Daig Livewire Steerable, Product Number 401582 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
- Medical device recall Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER 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
- Medical device recall Daig Livewire Steerable, Product Number 401652 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
- Medical device recall Daig Livewire Steerable, Product Number 401904 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
- Medical device recall Daig Livewire Steerable, Product Number 401905 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
- Medical device recall Daig Livewire Steerable, Product Number 401908 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
- Medical device recall Daig Livewire Steerable, Product Number 401914 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
- Medical device recall Daig Livewire Steerable, Product Number 401915 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
- Medical device recall Daig Livewire Steerable, Product Number 401923 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
- Medical device recall Daig Livewire Steerable, Product Number 401932 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
- Medical device recall Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER 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
- Medical device recall Medtronic Marinr Steerable, Product Number 72402 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
- Medical device recall LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL):… Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. 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 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the… Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in… 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 Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 Reloads for curved-tipped stapler may potentially produce an incomplete staple line. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic… Marker bands may be at an increased risk of cracking/breakage. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are… Marker bands may be at an increased risk of cracking/breakage. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20… Marker bands may be at an increased risk of cracking/breakage. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall VOCSN V+Pro package Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereCalifornia, Georgia, Missouri and Ohio
- Medical device recall Halyard CARDIAC CATH PACK kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard CARDIAC CATH PACK SAN23CARDQ kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard CARDIAC CATH TRAY SHANDS JAX kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard CATH LAB kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard CATH LAB kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard HEART CATH, SELF REGIONAL kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard NEURO IR PERIPHERAL (PS 64405) kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard PERC TRAY kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard SAMMC ANGIOGRAPHY kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Halyard VA DETROIT CATH LAB PACK kit Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereFlorida, Illinois, Missouri, Mississippi, North Carolina, Nebraska and Texas
- Medical device recall Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO… Impacted kits contain syringes recalled by Medline Industries. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedMay 13, 2026ClassClass IStatusOngoingWhereMinnesota
- Medical device recall Medical Action Industries Inc Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportArizonathe one state its words name PublishedMay 13, 2026ClassClass IStatusOngoingWhereArizona
- Medical device recall Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMay 13, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUX-DX II, Arrythmia detector and alarm For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LUX-Dx II Plus, Arrythmia detector and alarm For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prodisc C SK U.S Product labeling mix up. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee and Texas 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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