Medical DeviceFeb 19, 2020
Microvention Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil recall — FDA Z-1223-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Monthly breakdown
2020 recalls by month
Select a month to review the recall records reported during that period.
December 2020315 records · 4 categoriesNovember 2020241 records · 4 categoriesOctober 2020416 records · 4 categoriesSeptember 2020371 records · 4 categoriesAugust 2020245 records · 4 categoriesJuly 2020442 records · 4 categoriesJune 2020342 records · 4 categoriesMay 2020315 records · 4 categoriesApril 2020422 records · 4 categoriesMarch 2020368 records · 4 categoriesFebruary 2020551 records · 4 categoriesJanuary 2020224 records · 4 categories
2020 recalls — page 152
Records are ordered by the best available source date.
Medical DeviceFeb 19, 2020
Taewoong Medical Co Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F recall — FDA Z-1229-2020
Misprinted IFUs shipped with esophageal stents
Class IIFDA: TerminatedTaewoong Medical Co., Ltd.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID recall — FDA Z-1182-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Pacific Medical Group Ultrasound Transducer (M2736A), that may have been serviced with the recall — FDA Z-1167-2020
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical…
Class IIFDA: OngoingPacific Medical Group Inc.
Medical DeviceFeb 19, 2020
Flowonix Medical Prometra II 40mL Pump recall — FDA Z-1122-2020
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in…
Class IIFDA: OngoingFlowonix Medical Inc.
Medical DeviceFeb 19, 2020
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product recall — FDA Z-1109-2020
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 recall — FDA Z-1172-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Arrow International EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 recall — FDA Z-1197-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Pacific Medical Group Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may recall — FDA Z-1159-2020
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical…
Class IIFDA: OngoingPacific Medical Group Inc.
Medical DeviceFeb 19, 2020
Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to recall — FDA Z-1104-2020
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after…
Class IIFDA: TerminatedDexcom Inc.
Medical DeviceFeb 19, 2020
Flowonix Medical Prometra II Programmable 20mL Pump recall — FDA Z-1125-2020
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in…
Class IIFDA: OngoingFlowonix Medical Inc.
Medical DeviceFeb 19, 2020
Pacific Medical Group Toco+ transducer with ECG/IUP capability (wired), that may have been recall — FDA Z-1166-2020
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical…
Class IIFDA: OngoingPacific Medical Group Inc.
Medical DeviceFeb 19, 2020
Cardiac Assist TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product recall — FDA Z-1106-2020
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Class IIFDA: TerminatedCardiac Assist, Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E recall — FDA Z-1203-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code recall — FDA Z-1178-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated recall — FDA Z-1110-2020
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceFeb 19, 2020
Roche Diagnostics Operations cobas infinity core, Material No. 7154003001 recall — FDA Z-1158-2020
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceFeb 19, 2020
Arrow International EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH recall — FDA Z-1189-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931 recall — FDA Z-1153-2020
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen,…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceFeb 19, 2020
Flowonix Medical Prometra Programmable 20mL Pump recall — FDA Z-1120-2020
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in…
Class IIFDA: OngoingFlowonix Medical Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B recall — FDA Z-1201-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Flowonix Medical US Clinical 20mL Programmable Pump recall — FDA Z-1123-2020
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in…
Class IIFDA: OngoingFlowonix Medical Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code recall — FDA Z-1211-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceFeb 19, 2020
Arrow International EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI recall — FDA Z-1194-2020
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Class IIFDA: TerminatedArrow International Inc.
About the 2020 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.