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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jan 30, 2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... Class I Micro Therapeutics, Inc.
Jan 30, 2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... Class I Micro Therapeutics, Inc.
Jan 11, 2024 The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... European version of microcatheter were distributed within US which contain a different "Indicatio... Class II Micro Therapeutics, Inc.
Jan 11, 2024 The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... European version of microcatheter were distributed within US which contain a different "Indicatio... Class II Micro Therapeutics, Inc.
Jun 30, 2022 Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only Outer carton packaging of microcatheters were exposed to wet substance during transport. Class II Micro Therapeutics, Inc.
Jun 30, 2022 Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only Outer carton packaging of microcatheters were exposed to wet substance during transport. Class II Micro Therapeutics, Inc.
Apr 27, 2022 AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil Syst... Due to incorrect size and configuration labeling of the detachable coil system. Class II Micro Therapeutics, 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.