Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Siemens Atellica IM aTG Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM aTG Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia Ambition S Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FilmArray Gastrointestinal (GI) Panel, IVD Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EZ Derm Porcine Xenograft, labeled as the following: a Intermittent heat seal failures on the outer pouch of some EZ Derm products. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SOMATOM Confidence Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Edge Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Edge Plus Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode) Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement Report31 statesnamed in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Fetal Spiral Electrode During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MRIdian Linac Radiation Therapy System A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, Missouri, New York and Wisconsin
- Medical device recall CAROLINA(R) LIQUID CHEMISTRIES CORP Recalled by FDA on May 8, 2019 Class IIIFDA’s classMay 8, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 8, 2019ClassClass IIIStatusTerminatedWhereArkansas, California, Connecticut, Illinois, Maine, North Carolina, New Hampshire, New Jersey, New York, South Carolina and Texas
- Medical device recall CAROLINA(R) LIQUID CHEMISTRIES CORP Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. Class IIIFDA’s classMay 8, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 8, 2019ClassClass IIIStatusTerminatedWhereArkansas, California, Connecticut, Illinois, Maine, North Carolina, New Hampshire, New Jersey, New York, South Carolina and Texas
- Medical device recall G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is… The target values and ranges in these lots are incorrect. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereIllinois, North Carolina, Ohio, Pennsylvania, Puerto Rico, Wisconsin and West Virginia
- Medical device recall G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended… The target values and ranges in these lots are incorrect. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereIllinois, North Carolina, Ohio, Pennsylvania, Puerto Rico, Wisconsin and West Virginia
- Medical device recall Ethyl Alcohol Enzymatic Assay, (a) Shelf life of the product may be reduced due to degradation of the assay. Class IIIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 8, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Georgia, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, Oregon, South Carolina and Tennessee named
- Medical device recall Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Discovery NM/CT 670 CZT During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NM/CT 870 CZT During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine… During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading… Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall cone-beam CT system ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 1, 2019ClassClass IIStatusOngoingWhereNorth Carolina
- Medical device recall Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 1, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 1, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Aquarius CSF1R/RPS14 There is an error in the chromomap included in the labeling for the product. Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereIllinois and Tennessee
- Medical device recall Thoratec HeartMate 3 Coring Tool, Sterile EO Small black plastic particle was observed in the left ventricle during implant procedure. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, North Carolina, New York, Ohio, Oklahoma, South Carolina, Texas, Utah, Washington and Wisconsin named
- Medical device recall Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI… Advisory issued not to disable or bypass the AMP function. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RT Elements Software revisions of the RT Elements applications have a specific software version number There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when… Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft… Devices may generate excessive heat during use. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall OnSight 3D Extremity System- X-Ray, Tomography Computed System When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain… Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Georgia, Illinois, Minnesota, New York, Oregon and Pennsylvania named
- Medical device recall Truliant Tibial Fit Tray Cemented SZ 3F / 3T 2.5 Truliant Fit Trays were mismarked as 3 Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Indiana, Minnesota, New Jersey, Ohio, Oklahoma, South Carolina and Tennessee named
- Medical device recall Fresenius Kabi CATSmart device (Continuous autotransfusion System) Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software,… Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Covidien Endo Clinch II Auto Suture Grasper, 5mm Sterilization method used was not consistent with the labeling and the approved sterilization method Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Endo Grasp Auto Suture Grasper 5mm Sterilization method used was not consistent with the labeling and the approved sterilization method Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Procedure kits include devices from the affected lots Sterilization method used was not consistent with the labeling and the approved sterilization method Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TriMed Hex Cortical Screw 4.0, 40 mm The bone screw is shorter than the intended design specification. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereFlorida and Missouri
- Medical device recall Performance Series Sagittal Blade During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Idaho, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, Pennsylvania, Utah, Washington and Wisconsin named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.