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 Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall RS 5F DL XCELA PICC A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Part #: SAM XT-M Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report23 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kentucky, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Part #: SAM XT-C Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report23 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kentucky, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Part #: SAM XT-C Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report23 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kentucky, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall DermaPro Waterproof Silicone Tape, SNS57232 The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereAlabama and Ohio
- Medical device recall 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportOregonthe one state its words name PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser… It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under… Users have misinterpreted the display for out of range measurement indicated by the blinking” ---“ to mean a zero measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 13, 2018ClassClass IStatusTerminatedWhereNationwide, 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 Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under… Users have misinterpreted the display for out of range measurement indicated by the blinking “-0-“ to mean a zero measurement FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 13, 2018ClassClass IStatusTerminatedWhereNationwide, 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 nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain,… An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Restoris MCK Onlay Insert Extractor. Possible hinge pin disassociation from the Mako Onlay Insert Extractor. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Hobbs Bronchial Cytology Brushes Device was marketed for uses outside the 510(k) clearance. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Illinois, Maryland, New York, Tennessee, Texas and Virginia named
- Medical device recall ADVIA Centaur BNP (B-type Natriuretic Peptide) In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusOngoingWhereAlabama, California, Delaware, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra) In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusOngoingWhereAlabama, California, Delaware, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box Inadvertent shipment of expired units. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 13, 2018ClassClass IIStatusCompletedWhereMassachusetts
- Medical device recall RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical… Abnormal premature termination of the software could affect the use of the analyser when running patient samples. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals… The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT… Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180… The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr Foley Catheter with Incorrect Retainer Cap Print Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereFlorida, Minnesota, New York and Texas
- Medical device recall ST-AIA PACK AFP Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK CEA Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK PA Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK PAP Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK CA 19-9 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK 27.29 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK CK-MB Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK Myoglobin Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK cTnI 2nd Gen Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK C-Peptide Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK C-Peptide II Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK IRI Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIA-PACK TSH 3rd Generation Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK TT3 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK T4 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK FT3 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK FT4 Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK TU Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK ¿HCG Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA PACK HCG Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST-AIA DHEA-S Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results,… Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 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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