Browse Device Recalls
312 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 312 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 312 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to conta... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Upgrade to MR 7700; Model Number: 782130; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | 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.