Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall REF CH3020 40” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3625 5” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 011-H2864-HSR 180 cm Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 011-H3597 42 cm Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros” - Product Usage: provides access… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 20120-01 Spiros” Closed Male Luer - Product Usage: provides access for the administration of fluids from… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3034 5” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3235 30” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF CH3762 35” Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of… Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the… Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 19, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Grace Medical During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide, and 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, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Grace Medical During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide, and 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, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Grace Medical During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide, and 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, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall CareLink SmartSync Device Manager There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CRT-P Quad Models (CRT-Ps): a There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DJO EMPOWR KNEE Femoral Sizer Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereFlorida, Indiana and Minnesota
- Medical device recall Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias… A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Programmers - Product Usage: used to treat arrhythmias related to bradycardia A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used… The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 12, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Missouri, New York, Ohio, Tennessee and Texas named
- Medical device recall Medtronic Abre Venous Self-expanding Sent System Incorrect size printed on the device; packaging is labeled correctly. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 12, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Missouri, Montana and North Carolina named
- Medical device recall Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic… When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 12, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Delaware, Florida, Illinois, Indiana, Louisiana, Maine, Nebraska, New Jersey, Nevada, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube,… VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for… Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 12, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina and Texas named
- Medical device recall Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable… There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Illinois and Tennessee named
- Medical device recall Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. Potentially defective component in the AC power adapter which may fail over time. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Florida, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee and Texas named
- Medical device recall VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold… Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS¿ Black Reference Slides Delayed results. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to… Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a… Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic… May have been programmed with a less than optimal brightness setting resulting in a darker than desired image Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 5, 2021ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida and New Jersey named
- Medical device recall Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents Users may observe additional locus specific signals at 9q34. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Connecticut, Iowa, Illinois, Missouri, New York, Ohio and Texas named
- Medical device recall Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for… The incorrect dental pins were packaged and subsequently distributed. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Indiana, North Carolina, New Jersey, New York and Pennsylvania named
- Medical device recall Artis zee ceiling-interventional Fluoroscopic X-Ray System Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and… Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS… Siemens has become aware of a potential issue with software version VE20C. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall INFINITY_TRAY Custom Procedural Kit - Canada Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product… Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall InCore Lapidus Disposable Kit 28mm Left Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall InCore Lapidus Disposable Kit 28mm Right Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Stryker Medela Incorrect expiration date of “2023-07-24” on label of sterile tubing. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall Trinity Biotech Captia Measles IgM Kit Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Power Wheelchair Seat baseplate pin has broken in the field. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Scooter Seat baseplate pin has broken in the field. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital… Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusOngoingWhereNationwide
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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