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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Jul 15, 2021 | (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Prod... | The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magne... | Class II | Philips North America |
| 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 |
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.