Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall IMPAK Liquid Acrylic Resin Possible presence of foreign material (rust). Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, Michigan, New York, Ohio and Washington
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM The surface inside of the femoral component, where cement is applied for adhesion, is below specification. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IMPAK Liquid Acrylic Resin Possible presence of foreign material (rust). Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereMichigan, Minnesota, New Jersey, New Mexico, New York and Pennsylvania
- Medical device recall IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid Possible presence of foreign material (rust). Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereMichigan, Minnesota, New Jersey, New Mexico, New York and Pennsylvania
- Medical device recall Dako HER2 CISH pharmDx Kit An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, North Carolina and Pennsylvania named
- Medical device recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch,… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case,… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one… Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital… Software issues. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Texas
- Medical device recall Access Free T3 Assay Demonstrate an upward shift in patient results. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Big Bore Oncology tomography X-ray system scanner Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Big Bore Radiology tomography X-ray system scanner Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance CT Big Bore Oncology Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance iCT Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Flex Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Core 128 Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Core Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body… Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Kansas, Michigan, New York, Ohio and Texas named
- Medical device recall Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body… Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Kansas, Michigan, New York, Ohio and Texas named
- Medical device recall Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole… Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring… Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Kansas, Michigan, New York, Ohio and Texas named
- Medical device recall Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass 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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