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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ES1725KFX ESPOCAN SPINAL/EPID The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used by physicians to provide various… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by physicians to provide… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048,… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to… The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Clip Gun Magazines are The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications,… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging… There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hoffmann LRF Hexapod Software When creating a correction plan with the Correct Axial First button selected and the No. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Durex Real Feel Polyisoprene Condoms, 10 count and 24 count The products failed the filed specification of 1.0kPa for Burst Pressure. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement… Analyzers were distributed with software which lacks a 510K Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Oklahoma and Virginia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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