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 |
|---|---|---|---|---|
| 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 |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T. 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 |
| May 22, 2024 | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the f... | Potential for inaccurate fetal heart rate measurements when monitoring multiples. | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T TX for PET Model Number (REF): 781479 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T S Model Number (REF): 781347 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Initial system Model Number (REF): 781178 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems i... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical System... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indi... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | 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.