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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2020 Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c... Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) Class I Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jul 13, 2017 Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jul 13, 2017 Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland

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.