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 |
|---|---|---|---|---|
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| May 19, 2023 | DigitalDiagnost C90, Model No. 712034 and 712035 | There is a software login in issue that may prevent the user from logging in. | Class II | Philips North America Llc |
| Apr 25, 2023 | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 19, 2023 | Patient Information Center iX, Product Code 866386, and Patient Information C... | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... | Class II | Philips North America |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 17, 2023 | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ... | Class II | Philips North America Llc |
| Mar 9, 2023 | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 9, 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic imag... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 6, 2023 | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 6, 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 3, 2023 | CombiDiagnost R90 R1.1 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | CombiDiagnost R90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | ProxiDiagnost N90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Jan 18, 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an... | Class II | Philips North America |
| Nov 22, 2022 | Philips Upgrade to MR 7700 System, Model Number 782130 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips MR 7700 System, Model Number 782120 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 21, 2022 | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... | Class II | Philips North America Llc |
| Oct 21, 2022 | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Mode... | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a c... | Class II | Philips North America Llc |
| Sep 6, 2022 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This... | Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the... | Class II | Philips North America Llc |
| Mar 29, 2022 | The device is a whole-body CT x-ray system. The acquired x-ray transmission d... | Three software issues affecting incorrect image display, error interpreting patient images due to... | Class II | Philips North America Llc |
| Feb 25, 2022 | DigitalDiagnost C50 1.1 | Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... | Class II | Philips North America Llc |
| Feb 22, 2022 | Philips Hemodynamic Application, Model Number 722463, Software Version Number... | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode ... | Class II | Philips North America Llc |
| Feb 4, 2022 | Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart P... | There is a potential for AED pads to experience gel separation from the foam/tin backing when pee... | Class II | Philips North America LLC |
| Feb 4, 2022 | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARS... | There is a potential for AED pads to experience gel separation from the foam/tin backing when pee... | Class II | Philips North America LLC |
| Feb 2, 2022 | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029,... | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the ... | Class II | Philips North America Llc |
| Jan 6, 2022 | Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number ... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 98971... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 3, 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version ... | eCareManager (eCM) Sentry Score software not approved for use | Class II | Philips North America Llc |
| Nov 29, 2021 | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Heel Snuggler, Reference # 989805603411 99047 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 26, 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 24, 2021 | Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a ... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips North America Llc |
| Nov 24, 2021 | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluorosco... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips North America Llc |
| Nov 19, 2021 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended f... | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mount... | Class II | Philips North America Llc |
| Nov 12, 2021 | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging a... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | 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.