Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls.

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DateProductReasonClassFirm
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
Aug 10, 2023 Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SP... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 2... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Naviga... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univ... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Jul 18, 2023 Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical

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.