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 digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a… It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rusch Greenlite MAC 1 The pouch may contain the incorrect Rusch Green Lite product size. 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 Artis Q and Q.Zen Potential for liquid entry Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Zee and Zeego Potential for liquid entry Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078,… Potential for liquid entry Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q and Q.zen The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report51 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, West Virginia and Wyoming
- Medical device recall Artis zee and Artis zeego The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report51 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, West Virginia and Wyoming
- Medical device recall Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805,… The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report51 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, West Virginia and Wyoming
- Medical device recall ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies… An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. 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 SOMATOM Go.Up computed tomography (CT) x-ray system table The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New York and Tennessee named
- Medical device recall SOMATOM Go.Now computed tomography (CT) x-ray system table The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New York and Tennessee named
- Medical device recall AIRO Mobile CT System If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Allura Xper systems with Certeray X-ray Generator located in regions with high mains There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura… Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MEDISTIM VERIQ SYSTEM A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of… Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA… 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 Zimmer Segmental System, ZSS Distal Femur The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 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, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Versys 6 inch Beaded Full Coat Plus Hip Prosthesis The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 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, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Agility with Integrity R3.2 Potential for positional errors following automatic table movement (ATM). Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Integrity R1.2 Potential for positional errors following automatic table movement (ATM). Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Destination Guiding Sheath catheter introducer The tucking depth feature of this catheter introducer is marginally outside the upper specification. 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 Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use… The recalled units are mislabeled with an incorrect expiration date. 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 JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for… We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing production final acceptance testing due to a… Class IIIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall OptiView DAB IHC Detection Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ultraView Universal DAB Detection Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall iView DAB IHC Detection Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ultraView SISH Detection Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ultraView SISH DNP Detection Kit US, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CINtec PLUS Cytology Kit (CE-IVD), Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CINtec PLUS Cytology Kit (Canada/Japan), Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall OptiView Amplification Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall OptiView Amplification Kit Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Hematoxylin II, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ultraView SISH DNP Detection Kit, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cosmedent’s Etching Gel, 3g, 37% Phosphoric Acid Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Louisiana, Michigan, Pennsylvania and Wisconsin
- Medical device recall Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015) Product was placed into distribution prior to completion of all required post sterilization release activities. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Ohio, Oregon and Texas
- 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 Temperature Tubing 4”x100’ 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 Temperature Tubing 6”x100’ 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 Temperature Tubing 9”x100’ 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 Temperature Tubing 14”x100’ 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”x8” 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 4”x8” 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 10”x15” 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 16”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 13”x18” 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
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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