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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Vis-U-All High Temp 18”x22” Heat Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 4.5”x11” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 3.5”x22” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 5”x15” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 6”x10” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 7.5”x13.5” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 8”x10” Heat Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 8”x16” Heat Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 3.5”x9” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 16”x16” Self Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 13”x18” Self Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 18”x22” Self Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 10.5”x28” Self Seal Pouch 100 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 3.5”x22” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 4”x11” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 5.5”x10” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 5”x15” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 7.5”x13” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vis-U-All High Temp 8”x16” Self Seal Pouch 200 pouches per box On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 979195 Loaner Kit for femoral intramedullary nail Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue… Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3M Surgical Clipper Professional 9681 Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and… Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary… Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AVID TruCustom DAVINCI PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom DJ’S VASCULAR/NEURO TRAY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom OBSTETRICAL PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom PACEMAKER TRAY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom HEART CATH TRAY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom ORTHO TRAY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom CATH PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom EXTREMITY PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom GENERAL PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom GYN LAPAROSCOPY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom LAMINECTOMY PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom LOWER EXTREMITY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom MINOR PROCEDURE 6A convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom NEURO PK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom PACEMAKER PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom PLASTIC BASIN PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom PV MINOR PACK convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom SHOULDER ARTHROSCOPY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
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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