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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 13, 2025 | Product Name: Ingenia 1.5T CX; Model Number: 781262; | 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 3.0T CX; Model Number: 781271; | 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 3.0T; Model Numbers: (1) 782117, (2) 782143; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| Apr 7, 2025 | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt... | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possi... | Class II | Philips North America Llc |
| Apr 1, 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomogr... | Unintended motion issues related to Interventional Control that may lead to collision of the Gant... | Class II | Philips North America Llc |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Feb 25, 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guid... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Veradius Unity. Product Code 718132. The devices are used for radiological gu... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Zenition 70. Product Code 718133. The devices are used for radiological guida... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliBridge EC10 Module. Model Number: 865115 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX500. Model Number: 866064 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX550. Model Number: 866066 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX450. Model Number: 866062 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX400. Model Number: 866060 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Nov 20, 2024 | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | The following four issues are included: 1. Certain Channel Settings may result in an Access Poi... | Class II | Philips North America Llc |
| Nov 16, 2024 | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... | Class II | Philips North America Llc |
| Nov 4, 2024 | Achieva TX Interventional Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Diagnostic Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Interventional Coil 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | ST SENSE Breast Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 16ch 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 7ch 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | SENSE Breast Coil 3.0T 7ch | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | SENSE Breast Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | ST SENSE Breast Dx Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 7ch 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Diagnostic Coil 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Interventional Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 16ch 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Sep 3, 2024 | MR 7700 -For use as a diagnostic device to obtain cross-sectional images, sp... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | MR 5300 - For use as a diagnostic device to obtain cross-sectional images, sp... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional i... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional i... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-secti... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional im... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional image... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Aug 30, 2024 | IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8... | During a production process, Philips became aware of one IntelliVue power supply with a broken gr... | Class II | Philips North America |
| Jun 28, 2024 | IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x ent... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdo... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | 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.