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Browse Device Recalls

66 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 66 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 66 FDA device recalls.

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DateProductReasonClassFirm
Apr 22, 2016 SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemen... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT X-4R, Model Number 10248670 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT Flow Edge-4R, Model Number 10528955 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT S(40)-4R, Model Number 10248671 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT S(64)-4R, Model Number 10248672 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Nov 13, 2014 Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biogra... Possibility for system display freeze during CT interventional procedures. Class II Siemens Medical Solutions USA Inc.
Nov 13, 2014 Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biog... Possibility for system display freeze during CT interventional procedures. Class II Siemens Medical Solutions USA Inc.
Nov 13, 2014 Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Bi... Possibility for system display freeze during CT interventional procedures. Class II Siemens Medical Solutions USA Inc.
Nov 13, 2014 Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biogra... Possibility for system display freeze during CT interventional procedures. Class II Siemens Medical Solutions USA Inc.
Nov 13, 2014 Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph m... Possibility for system display freeze during CT interventional procedures. Class II Siemens Medical Solutions USA Inc.
Jan 18, 2013 ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 ... On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. Class II Siemens Medical Solutions USA, 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.