Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1396-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Latest records
Latest recalls — page 1066
The newest recall records with useful source details are listed here.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference recall — FDA Z-1386-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1405-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF recall — FDA Z-1399-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Siemens Healthcare Diagnostics ADVIA Chemistry Lipase, Ref recall — FDA Z-1363-2020
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference recall — FDA Z-1388-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1402-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1398-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Siemens Medical Solutions USA COHERENCE Oncologist, Model Nos. 07333680 & 07351898 recall — FDA Z-1346-2020
A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference recall — FDA Z-1375-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference recall — FDA Z-1379-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1394-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Maquet Cardiovascular Us Sales Getinge 46-Series Washer Disinfector Model # 46-4, Part recall — FDA Z-1391-2020
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the…
Class IIIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference recall — FDA Z-1381-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a recall — FDA Z-1389-2020
Perfusion tubing pack was packaged with the incorrect cuvette.
Class IIIFDA: TerminatedLivaNova USA Inc.
Medical DeviceMar 4, 2020
Cook Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL recall — FDA Z-1355-2020
The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU…
Class IIFDA: TerminatedCook Inc.
Medical DeviceMar 4, 2020
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink recall — FDA Z-1350-2020
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Class IIFDA: Terminatedulrich medical USA Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference recall — FDA Z-1377-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference recall — FDA Z-1383-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference recall — FDA Z-1372-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC recall — FDA Z-1406-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference recall — FDA Z-1382-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Exactech Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used recall — FDA Z-1364-2020
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference recall — FDA Z-1374-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
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Recent recall archives
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October 2026180 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories