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 7, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Halo Closed System Transfer Device, closed syringe adaptor Product malfunction: Needle does not retract. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereMaryland, Texas and Wisconsin
- Medical device recall Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of… Failure to correctly document the installation of four M12 Bolts into the system rotor. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for… There’s a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography… Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Indiana, Louisiana, Massachusetts, Minnesota, Oregon, Tennessee and Texas named
- Medical device recall AxIEM Touch N Go Pointer Probe Medtronic Navigation, Inc. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REFLECTION(R) DEAD BLOW MALLET The firm received complaints of cracks in the weld on the head of the mallet. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external… Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, Kentucky, Massachusetts, North Carolina, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall symmetry surgical ULTRA(R) Steam container Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall symmetry surgical ULTRA(R) Sterrad container Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall symmetry surgical ULTRA(R) Gravity container Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UniCel DxH 800 Coulter Cellular Analysis System Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DxH 600 Coulter Cellular Analysis System Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Infant Warmer System (IWS) GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the… Hospira, Inc. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report52 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure… OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Michigan, Missouri, Nebraska, Ohio, Pennsylvania and Texas
- Medical device recall Reunion TSA Peg Alignment Sound Reunion TSA Peg Alignment Sound broke during surgery. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill Potential contamination with B. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 11, 2017ClassClass IStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Boston Scientific, INGEVITY” MRI Leads, Sterile EO, RxOnly. Boston Scientific is conducting a recall on Boston Scientific INGEVITY” MRI endocardial pacing leads. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereIowa and New York
- Medical device recall DR Systems Unity PACS software, now known as Merge Unity PACS software. The software fails to associate to the correct MG image if there are two images for the same view. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereCalifornia, Montana, Pennsylvania and Texas
- Medical device recall TVC Imaging System Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow… Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall G3 Opticage Expandable Interbody Fusion Device During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Delaware, Georgia, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1) The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROFEMUR(R) R RASP HANDLE The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for… All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals… All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals… All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gomco Circumcision Clamps with separate O-Ring Component: The device is Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GalaSHAPE 3D Endotoxin values from testing of retains slightly exceeded the established specification. Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Michigan, Montana and Nevada named
- Medical device recall PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is… Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter… Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NeuViz 64 Multi-slice CT Scanner Systems The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NIM EMG Endotracheal Tube, 6.0 mm I.D Wire in tubing can become exposed, posing potential harm to the intubated patient. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate… Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, New Jersey, Nevada, Ohio and South Carolina
- Medical device recall VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Innova 2000 GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVANTX LCA GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVANTX LCLP+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVANTX LCN+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVANTX LCV+ GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
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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