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 |
|---|---|---|---|---|
| Sep 24, 2021 | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Va... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Azurion series (within the limits of the used Operation Room table) are i... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Vas... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for u... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for u... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicate... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 16, 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 Y... | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy... | Class II | Philips North America LLC |
| Jun 8, 2021 | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-r... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iC... | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728332 IQon Spectral CT-Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| Jun 8, 2021 | 728333 Spectral CT 7500 -Computed Tomography X-ray system | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Prot... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| Apr 23, 2021 | Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 23, 2021 | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated ... | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 13, 2021 | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to pro... | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury | Class II | Philips North America Llc |
| Mar 29, 2021 | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... | 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.