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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Nov 19, 2013 Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-pa... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,sing... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-pack... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-pac... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-pac... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-p... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, 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.