Browse Device Recalls

477 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 477 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 477 FDA device recalls.

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DateProductReasonClassFirm
Aug 28, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R1... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S),... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software V... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; So... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 a... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 78... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. ... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; So... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 21, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 5300 Model Number (REF): 1. 782110, 2. 782152; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 18, 2026 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots ma... Class II Philips North America Llc
Aug 7, 2026 Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Jul 31, 2026 Philips Patient Information Center iX REF:866389 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 31, 2026 Philips PIC iX Essentials REF:867093 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 1, 2026 Cardiac Workstation 7000. Product Number: 860441. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jul 1, 2026 Cardiac Workstation 5000. Product Number: 860439. Device will intermittently provide inaccurate data related to native heart rate. Class II Philips North America Llc
Jun 5, 2026 Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... Class II Philips North America Llc
May 26, 2026 Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... Class II Philips North America Llc
May 26, 2026 Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... Class II Philips North America Llc
May 1, 2026 DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to pr... Class II Philips North America Llc
Apr 14, 2026 Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America

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.