Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use… Perfusion tubing pack was packaged with the incorrect cuvette. Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Getinge 46-Series Washer Disinfector Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Iowa, Minnesota, New York, South Carolina and Virginia
- Medical device recall Getinge 46-Series Washer Disinfector Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Iowa, Minnesota, New York, South Carolina and Virginia
- Medical device recall MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical,… The devices may be missing the implant coil. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, International Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, Iberia Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, Germany Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, EU Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Garbin EVO Ventilator, Linde Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, Great Britain Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, Nordics Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, France Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, 02 - International Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, 02 - Italy Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, 02 - Iberia Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Trilogy EVO Ventilator, 02 - EU Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall LifeVent EVO Ventilator, 02 Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
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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