Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall VNS Therapy Programmer False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3)… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Captus 4000e Thyroid Uptake System It is possible that the collimators have screw hole locations that were insufficiently tapped. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pericardiocentesis Set, Irrigation Catheter, Reference The printed expiration dates are incorrect. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereColorado, Delaware, Maryland, Minnesota, North Carolina, Nevada and West Virginia
- Medical device recall Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference The printed expiration dates are incorrect. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereColorado, Delaware, Maryland, Minnesota, North Carolina, Nevada and West Virginia
- Medical device recall Encina HA Femoral Stem, Size 11 Coxa Vara Collared The firm has identified that packaging containing components of the hip replacement range are mislabeled. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 1, 2020ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27” max Potential for the weld to fail at the pivot point of the monitor bracket. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereArizona, Colorado, Georgia, Illinois, Michigan, Minnesota, New Jersey, Pennsylvania, Virginia and Vermont
- Medical device recall 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 BardPort M.R.I Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 BardPort M.R.I Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter,… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous… Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, 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 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 LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01)… Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MiniMed Insulin Pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MiniMed Paradigm The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MiniMed Paradigm 512 Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Veo Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic MiniMed Paradigm Veo Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage… The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RayStation standalone software treatment planning system Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedApr 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112 The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575,… Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 25, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 25, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, 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, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall Teleflex Pilling Aortic Punch, 4.0mm The sterile packaging has the potential to be compromised. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit Custom surgical kits contain a plate different than indicated by the package labeling. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNew York
- Medical device recall TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on Custom surgical kits contain a plate different than indicated by the package labeling. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Allura Exper FD Series A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integris Allura 9, system codes 722018 722021 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
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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