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 GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System A detector can detach and fall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 21, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 21, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System A detector can detach and fall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 21, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 21, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall GE Healthcare Millennium MC A detector can detach and fall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 21, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 21, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Aisys Anesthesia System Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Aisys CS2 Anesthesia System Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Touchscreen display kit Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BioMend Extend, REF# 0142Z, Synthetic bone grafting material. There is a possibility that the product was packaged in the wrong box. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereFlorida
- Medical device recall OviTex Reinforced BioScaffold 4x8cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 6x10cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 10x12cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 10x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 16x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 20x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 4x8cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 6x10cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 10x12cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 10x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 16x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 18x22cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 1S Reinforced BioScaffold 20x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 6x10cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 10x12cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 10x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 16x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 18x22cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 20x20cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex Reinforced BioScaffold 18x22cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall OviTex 2S Reinforced BioScaffold 10x12cm Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire and New York
- Medical device recall The Spirit Plus Bed The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlaska, 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 and Wyoming
- Medical device recall The Spirit Select Bed The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereAlaska, 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 and Wyoming
- Medical device recall INFUSE Bone Graft X SMALL KIT The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Heron toilet and bath chair Replacement campaign on all units that have a gas spring head in aluminum. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack There is potential to break during use. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134 Some eluates become colored because of remaining hemoglobin in the eluate. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product… Label was incorrect. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Montana, North Carolina and New Jersey named
- Medical device recall VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In… Potential to lead to a false negative results. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Indiana, Kentucky, Minnesota, Missouri, New Jersey, Ohio, Texas and Wisconsin named
- Medical device recall Affixus Hip Fracture Nail Left Deg 9x300mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail Left 125 Deg 11x300mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail Left 130 Deg 11x300mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail Left 125 Deg 9x165mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail 125 Deg 10x165mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail 125 Deg 12x165mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail 130 Deg 10x165mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Affixus Hip Fracture Nail 130 Deg 12x165mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, 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 Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic… Laser engraved label does not match with the item in the package Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Texas and Virginia named
- Medical device recall Powdered Surgical Gloves, labeled as: a Powdered Surgical Gloves are an FDA banned substance. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereIllinois, Missouri, Nebraska and Ohio
- Medical device recall ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a… Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass 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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