Browse Device Recalls
440 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 440 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 440 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, 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. CT 6000, Model Number: 728... | 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 Family Brazil... | 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. Big Bore RT, Model Number:... | 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. IQon Spectral CT, Model Nu... | 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 iCT, Model Numb... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Jun 30, 2025 | Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Intera 3.0T Quasar Dual Model Number (REF): 781150; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Upgrade to MR 7700 Model Number (REF): 782130; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T S Model Number (REF): 781347; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for 3.0T Model Number (REF): 782145; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| May 29, 2025 | Achieva XR Product Numbers: (1) 781153, (2) 781253; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Omni/Stellar; Product Number: 781104; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Master/Nova Product Number: 781106; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera Achieva 1.5T Pulsar; Product Number: 781171; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova Product Number: 781172; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva IT Nova Product Number: 781175 | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | 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.