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 EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts 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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