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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Product 21 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 22 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 23 consists of all As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 24 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 25 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 26 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 27 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 28 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 29 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 30 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 31 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 32 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 33 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 34 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 35 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 36 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 37 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 38 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 39 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 40 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 41 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 42 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 43 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 44 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 45 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 46 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 47 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 48 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 49 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 50 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 51 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 52 consists of As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 53 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 54 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 55 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 56 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 57 consists of all As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 58 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 59 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 60 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 61 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 62 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 63 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 64 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 65 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 66 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 67 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 68 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 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.”
Your shortlist0 of 4
Add one more to compare.