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 Legacy 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 Precision 500D 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 Prestige II 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 Prestige SI 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 Prestige VH 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 Prestilix 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 RFX 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 SFX 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 Shimadzu X-ray TV System Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Montana, Nebraska, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas and Washington
- Medical device recall Shimadzu X-ray High Voltage Generator Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArizona, California, Florida, Louisiana, New Jersey, South Carolina and Washington
- Medical device recall SOMATOM Scope, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArkansas, Georgia, Illinois, Indiana, Maryland, Michigan, New York, Oklahoma, South Carolina and South Dakota
- Medical device recall SOMATOM Scope Power, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArkansas, Georgia, Illinois, Indiana, Maryland, Michigan, New York, Oklahoma, South Carolina and South Dakota
- Medical device recall SOMATOM Perspective, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to… Class IIFDA’s classJan 4, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereArkansas, Georgia, Illinois, Indiana, Maryland, Michigan, New York, Oklahoma, South Carolina and South Dakota
- Medical device recall Arthex S3 Arm Sleeve Connector During use, the unit could separate un-expectantly. Class IIFDA’s classJan 4, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 4, 2017ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
- Medical device recall Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the… Sterling Diagnostics, Inc. Class IIIFDA’s classJan 4, 2017in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 4, 2017ClassClass IIIStatusTerminatedWhereMichigan
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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