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.

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DateProductReasonClassFirm
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.