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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
Aug 20, 2019 TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Aug 20, 2019 TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... Class II Quality Electrodynamics LLC
Jul 27, 2012 TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scann... On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not function... Class II Quality Electrodynamics LLC

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.