Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 |
| May 3, 2024 | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 1, 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an op... | Class II | Alere San Diego, Inc. |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Nov 17, 2023 | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7... | Firm was informed of an event in which the structural integrity of the MR system components faile... | Class I | Philips North America Llc |
| Nov 3, 2023 | Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 ... | Class II | Liberty Medical Solutions, LLC |
| Oct 19, 2023 | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 17, 2023 | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base w... | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of... | Class II | BioFire Diagnostics, LLC |
| Oct 2, 2023 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... | There is a potential for unexpected failure of the electrical components within the Carestream He... | Class II | Carestream Health, Inc. |
| Oct 2, 2023 | DRX Revolution Mobile X-Ray System | Unexpected failure of electrical components within the CPI generator. | Class II | Carestream Health, Inc. |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-L-200 | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | Citrine QTRAP Mass Spectrometer, Part Number 5063685 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 300900000000, | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-Z-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | API3200MD Mass Spectrometer, Part Number 4466230 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LE-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-L-100. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | Citrine Triple Quad Mass Spectrometer, Part Number 5063684 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LE-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 10, 2023 | Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
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.