Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Zilver 635 Biliary Stent 12mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 4mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 20mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 12mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 4mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 20mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 5mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver Biliary 518 Stent 5mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Zilver 635 Biliary Stent 14mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Intelligent Peri-Analytical Workstation (HW+SW) Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Software Package, Sorting-Drive 4.2 User Kit Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10 Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Software Package, iPAW 4.2 User Kit Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10 Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1) Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1) Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of… Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and… The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Volumat MC Agilia Volumetric Infusion Pump Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile… Potential ability to leak once used for compounding. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile… Potential ability to leak once used for compounding. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile… Potential ability to leak once used for compounding. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile… Potential ability to leak once used for compounding. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile… Potential ability to leak once used for compounding. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Nevada, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall EVO Excel, Emission Computed Tomographic System, Material Number 10910501 The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
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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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