Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Artis Zee and Zeego fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Axiom Artis fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall iConnect Enterprise Archive when used with RadSuite The software produced a number of ”do not route” exceptions, which may result in potential patient injury or delay in diagnosis or treatment. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 22, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall BNX Fine Need Aspiration System Handle may break during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall SharkCore Fine Needle Biopsy System Handle may break during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall SharkCore Fine Needle Biopsy System Handle may break during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall SharkCore LG Fine Needle Biopsy System Handle may break during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall BNX Fine Need Aspiration System Handle may break during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall C2 CryoBalloon Ablation System - Controller Cap The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inion GRT Tack, drill bit and tack appl., 4x, Sterile Aluminum pouch seal was noticed to be defective (slightly open). Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereFlorida and North Carolina
- Medical device recall 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear… Four issues: 1. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies Four issues: 1. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies Four issues: 1. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MaxGuard Extension Set CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall .045 X 6 ST Guide Wire Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical… The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip) The product was not functioning as intended. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Indiana, South Carolina and Texas named
- Medical device recall Remel, Haemophilus Test Medium (Agar) in A) 100 mm Test organisms exhibit poor growth when grown using the test agar. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a… Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWherePuerto Rico and US Virgin Islands
- Medical device recall CaviWipes1 Extra Large Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Illinois, Minnesota, New York, Pennsylvania and Texas named
- Medical device recall Merge Cardio software When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection,… Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 15, 2017ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Florida, Georgia, Hawaii, Louisiana, New Jersey, Nevada, New York, Pennsylvania and Washington named
- Medical device recall A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereMontana and Nevada
- Medical device recall A-series lift - A625 Manual During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereMontana and Nevada
- Medical device recall MicroAire K-Wires Mislabeling on three lots of K-Wires. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Premier Guard Sterile Drape For Use with Blair-Port Wand Sterility compromised due to breach in sterile barrier Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Premier Guard Drape, Sterile Sterility compromised due to breach in sterile barrier Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The UNI-CP System The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect. Class IIIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Turon Impaction Fixture During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall RSP Impaction Fixture During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the… The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Roth Net Polyp Retrieval The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. Class IIIFDA’s classMar 15, 2017in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 15, 2017ClassClass IIIStatusTerminatedWhereAlabama, California, Colorado, Illinois, Kansas, Massachusetts, Montana, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall ADVIA Centaur Progesterone DHEA-S causes falsely elevated progesterone results. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Dimension Vista LOCI Progesterone DHEA-S causes falsely elevated progesterone results. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IMMULITE/ IMMULITE 1000 Progesterone DHEA-S causes falsely elevated progesterone results. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IMMULITE 2000 Progesterone DHEA-S causes falsely elevated progesterone results. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by… The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Washington, Wisconsin and Wyoming named
- Medical device recall Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by… The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Washington, Wisconsin and Wyoming named
- Medical device recall Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized… The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Washington, Wisconsin and Wyoming named
- Medical device recall Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be… The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Washington, Wisconsin and Wyoming named
- Medical device recall DR Systems Unity PACS software, now known as Merge Unity PACS Reports were missing demographic header information when they were faxed to referring physicians. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereCalifornia, Montana, Pennsylvania and Texas
- Medical device recall Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs… Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named
- Medical device recall Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131… Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named
- Medical device recall Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine… Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named
- Medical device recall Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine… Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah 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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