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 Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent… Patient results may be falsely elevated. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent… Patient results may be falsely elevated. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an… Devices were delivered without the required dry ice. Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Arrow PICC powered by Arrow VPS Precision Stylet Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC powered by Arrow VPS Precision Stylet Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neuro Omega System, incorporating HaGuide software If cables are improperly connected, current may reach high charge density, causing tissue harm. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 15, 2019ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Ohio, Pennsylvania, Rhode Island, Texas and Virginia named
- Medical device recall Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in… Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ChemoPlus Chemo Spill Kit Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ChemoPlus Chemo Spill Kit Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ChemoPlus Protective Wrap-around Goggles Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ChemoPlus Chemo Spill Kit, Home Health Kit Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ 5600 Integrated System -Software V3.3.2 & below Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ ECi/ECiQ Immunodiagnostic System Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS ECi Immunodiagnostic System Refurbished Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry… Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is… Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the… Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and North Carolina named
- Medical device recall Abbott ARCHITECT cSystems ICT Module There is a potential to generate falsely elevated serum or plasma chloride results when using the product. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Mississippi, New Jersey, New York, Pennsylvania, South Carolina, Texas, Vermont, Washington and West Virginia named
- Medical device recall Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation… There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has… Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Texas and Wisconsin named
- Medical device recall Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray… Continuous operation at very high tube output may result in increased wear of the radiation emitting components. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Atellica IM 1300 Analyzer, Material Number 11066001 There were multiple issues identified in the system software which required an update. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia and Wyoming
- Medical device recall Atellica IM 1600 Analyzer, Material Number 11066000 There were multiple issues identified in the system software which required an update. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia and Wyoming
- Medical device recall Atellica Sample Handler Prime, Material Number 11069001 There were multiple issues identified in the system software which required an update. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia and Wyoming
- Medical device recall T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and… There is a potential of fracture, bending or shearing of the driver. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and… There is a potential of fracture, bending or shearing of the driver. Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall ConMed Anchor Tissue Retrieval System 10 MM, 235 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConMed Anchor Tissue Retrieval System”, 12 MM, 300 ML Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block,… Product mislabeling. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida and Massachusetts named
- Medical device recall OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block,… Product mislabeling. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida and Massachusetts named
- Medical device recall Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur 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 SiemensADVIA Centaur 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
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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