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Browse Device Recalls

23 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 23 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 23 FDA device recalls.

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DateProductReasonClassFirm
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Aug 7, 2017 MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref G... There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. Class II Microvention, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.