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 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Certain Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Implant EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Implant Straight Cover Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain IOL Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Locator Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Micromini Flat Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Non-Hexed Implant Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Preformance 15 degrees Pre-Angled Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Preformance Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Preformance Temporary Cylinder Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Provide Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Standard Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Straight Healing Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Straight Pick Up Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Temporary Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Temporary Non-Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Titanium Large Hexed Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Twist Lock TM Straight Transfer Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Conical 17 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Conical 25 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Conical Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Conical Abutment Gold Standard ZR TM Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Conical Abutment Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Bellatek Encode Healing Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Bellatek Encode Healing Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Conical 17 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Conical 25 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Conical Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Cover Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Healing Abutment Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Pick-Up Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Flat Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue TM 15 degree Angled Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue 15 degree Pre- Angled Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue 15 degree Angled Post Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall AB Sciex API 3200MD” LC/MS/MS System MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AB SCIEX Triple Quad 4500MD LC/MS/MS System MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perioscopy Sheath The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality… Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 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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