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 The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a… Lack of 510K clearance Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Workstation, G2, Configured (P/N 000-0241) Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereCalifornia, Illinois, New York, Rhode Island and Texas
- Medical device recall Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is… Negative Bias with Lot EA9227. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement Report35 statesnamed in where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2019in FDA’s Enforcement ReportArkansasthe one state its words name PublishedAug 7, 2019ClassClass IStatusTerminatedWhereArkansas
- Medical device recall Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is… The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rusch EasyCath Kit Potential for product not to be sterile. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Carolina, New Jersey, Ohio, Oklahoma and Texas named
- Medical device recall Maximum Pelvic Trainer (MPT) The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 7, 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, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Filter-Tips, 1500 ul Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Acuject Variable Injection Needle Potential for occluded injection needles. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Flexible Drill Shaft, FMP Acetabular System Instrumentation Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusOngoingWhereArizona, Missouri, Mississippi, New York, Oklahoma and Utah
- Medical device recall Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge… Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 7, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall A&E Medical Corp Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions… Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an… The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, Montana, New York, South Carolina, Texas and Utah named
- Medical device recall Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into… Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into… Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Frontal Stretch Buckle Closure Apron, Product Number A-10 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Frontal Apron Velcro Closure, Product Number F-17 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Frontal Support Belt Apron, Product Number F-15 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Frontal Quick Drop OR Apron, Product Number 601 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1 pc Full Wrap Support Belt Apron, Product Number F111 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2 pc Full Wrap Vest & Kilt, Product Number VK The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vest, Single Item, Product Number Vest The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Overlap Vest, Single Item, Product Number FVest The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Peak Vest, Single Item, Product Number PVest The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kilt, Single Item, Product Number Kilt The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thyroid Collar, Magnetic Closure, Product Number TS5 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thyroid Collar, Velcro Closure, Product Number TS2 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thyroid Collar, Buckle Closure, Product Number TS4 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sleeve, Product Number Sleeve The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Front/Back Apron with Stretch Velcro Closure, Product Number EURO The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Half Apron, Product Number Half Apron The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cap, Product Number Cap The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hood, Product Number Hood The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Porta Shield, Product Number Porta Shield The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thyroid Collar Oversize, Product Number TS3 The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be… Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, Texas and Vermont named
- Medical device recall GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended… Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, Texas and Vermont named
- Medical device recall Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kansas, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended… Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 7, 2019ClassClass IIStatusCompletedWhereTexas
- Medical device recall Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement… Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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.”
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