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.

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DateProductReasonClassFirm
Sep 21, 2023 DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Sep 21, 2023 DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... Potential for units suspended on the ceiling to fail and fall. Class II Philips North America Llc
Aug 31, 2023 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 17, 2023 Patient Information Center iX with Software Version Number 4.x in the followi... Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... Class II Philips North America Llc
Jun 14, 2023 IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01... Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco... Class II Philips North America Llc
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
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
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 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
Nov 12, 2021 Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 wi... (1)Start-up problem: Intermittently at start-up of the system, the communication of the control u... Class II Philips North America Llc
Nov 12, 2021 BV Endura 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
Oct 29, 2021 Wireless Footswtich used with the following Philips Allura Xper and Azurion I... Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure Class II Philips North America Llc
Oct 21, 2021 ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... Class II Philips North America Llc
Oct 21, 2021 CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... 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.