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
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.