Browse Device Recalls

335 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 335 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 335 FDA device recalls.

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DateProductReasonClassFirm
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 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
Jan 7, 2026 Spectral CT 7500 on Rails; Product Code (REF): 728334; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 IQon Spectral CT; Product Code (REF): 728332; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 Spectral CT; Product Code (REF): 728333; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Jan 7, 2026 Brilliance iCT; Product Code (REF): 728306; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... Class II Philips North America Llc
Dec 12, 2025 Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead... Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP70. Product Number: M8007A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX450. Product Number: 866062. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX750. Product Number: 866471. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX550. Product Number: 866066. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Multi-Measurement Module X3. Product Number: 867030. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX400. Product Number: 866060. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX600. Product Number: 865242. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP20. Product Number: M8001A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP5. Product Number: M8105A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP60. Product Number: M8005A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Multi Measurement Server X2. Product Number: M3002A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP40. Product Number: M8003A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX100. Product Number: 867033. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP80. Product Number: M8008A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP50. Product Number: M8004A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP2. Product Number: M8102A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX850. Product Number: 866470. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX500. Product Number: 866064. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX700. Product Number: 865241. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX800. Product Number: 865240. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP30. Product Number: M8002A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP90. Product Number: M8010A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America 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.