Medical DeviceFeb 19, 2020
Microvention Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil recall — FDA Z-1220-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Latest records
Latest recalls — page 1077
The newest recall records with useful source details are listed here.
Medical DeviceFeb 19, 2020
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742 recall — FDA Z-0956-2020
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a…
Class IFDA: OngoingMedtronic Inc.
Medical DeviceFeb 19, 2020
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product recall — FDA Z-1108-2020
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
LivaNova USA VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 recall — FDA Z-1118-2020
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code recall — FDA Z-1170-2020
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
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and recall — FDA Z-0957-2020
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a…
Class IFDA: OngoingMedtronic Inc.
Medical DeviceFeb 19, 2020
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for recall — FDA Z-1149-2020
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Class IIFDA: TerminatedBlue Ortho
Medical DeviceFeb 19, 2020
LivaNova Sorin Connect DPIII KOMPL recall — FDA Z-1119-2020
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the…
Class IIIFDA: TerminatedLivaNova USA Inc.
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP recall — FDA Z-1207-2020
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 BE-05400-DCSHO recall — FDA Z-1190-2020
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-1183-2020
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 Epidural Catheterization Kit, Product Code ASK-05501-SH recall — FDA Z-1180-2020
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 with FlexTip Plus Catheter, Product Code recall — FDA Z-1213-2020
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 AT-05501-LIN recall — FDA Z-1187-2020
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-1184-2020
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, 4 Inch, Catalog Number 801805 - Product Usage recall — FDA Z-1111-2020
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 Set, Product Code MTO-05500-TK recall — FDA Z-1209-2020
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
Nextremity Solutions Stratum Lapidus Plate - Small Rt, Part No recall — FDA Z-1127-2020
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceFeb 19, 2020
Stryker recall — FDA Z-1147-2020
Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This…
Class IIFDA: TerminatedStryker Corporation
Medical DeviceFeb 19, 2020
Flowonix Medical Prometra Programmable 20mL Pump recall — FDA Z-1124-2020
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 Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that recall — FDA Z-1162-2020
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
Arrow International EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 recall — FDA Z-1198-2020
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
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once recall — FDA Z-1103-2020
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the…
Class IIFDA: OngoingFridababy LLC
Medical DeviceFeb 19, 2020
Arrow International FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 recall — FDA Z-1177-2020
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.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
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