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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jan 22, 2021 ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U... Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section... Class I Acist Medical Systems
Dec 21, 2015 ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT20... Reports related to ingress of air into the manifold. Class II Acist Medical Systems
Mar 15, 2013 ACIST Medical Systems Inc. The ACIST Angiographic Injection System is inte... ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Auto... Class II Acist Medical Systems

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.