Browse Device Recalls

421 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 421 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 421 FDA device recalls.

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DateProductReasonClassFirm
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 22, 2025 Patient Information Center iX; Software Version Number: 4.5.0 A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... Class II Philips North America
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
Dec 3, 2025 Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
Dec 3, 2025 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... Class II Philips North America
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
Oct 29, 2025 Incisive CT; Software Version Number: 4.5, 5.0, 5.1; If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci... Class II Philips North America Llc
Oct 29, 2025 CT 5300; Software Version Number: 4.5, 5.0, 5.1; If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci... Class II Philips North America Llc
Oct 27, 2025 Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVE... Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped ... Class II Philips North America
Sep 12, 2025 Cardiac Workstation 7000; Model Number: 860441; Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... Class II Philips North America
Sep 12, 2025 Cardiac Workstation 5000; Model Number: 860439; Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... Class II Philips North America
Aug 13, 2025 Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... 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.