Browse Device Recalls

3,235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,235 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 3,235 FDA device recalls.

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DateProductReasonClassFirm
Jun 14, 2024 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.
Jun 3, 2024 QIAcube Connect MDx - IVD Instrument designed to perform automated isolation ... Heater shaker module does not perform heating if the temperature is set below 40¿C for static inc... Class II Qiagen Sciences LLC
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Soft... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 23, 2024 Surgical Image Guidance Functionality, software used with NGENUITY 3D Visuali... After surgery initiation, while using surgical image guidance, if significant eye rotation/moveme... Class II Alcon Research LLC
May 22, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoas... Class II Beckman Coulter, Inc.
May 22, 2024 DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) ... Class II Beckman Coulter, Inc.
May 21, 2024 BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Due to a software issue the PC unit may not connect to the server which could impact wireless dat... Class II CareFusion 303, Inc.
May 17, 2024 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... Class II Siemens Healthcare Diagnostics Inc
May 16, 2024 Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: ... When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 16, 2024 Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model ... When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 16, 2024 Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: ... When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 15, 2024 A610 Clinician Programmer (CP) Software Application (app) with the following ... Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI ... Class II Medtronic Neuromodulation
May 9, 2024 Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is par... Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccur... Class II Echonous Inc
May 7, 2024 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... Class II Blue Belt Technologies, Inc
May 2, 2024 BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; An... If automated dispensing cabinets have specific software versions, and Component Manager was confi... Class II CareFusion 303, Inc.
May 2, 2024 Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Softw... Potential for pressure wave data synchronization from two devices may not be correct. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 29, 2024 Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 ... Due to software issues, their is the potential for loss of image or a degradation of the image wh... Class II Verathon, Inc.
Apr 29, 2024 Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Sof... Due to software issues, their is the potential for loss of image or a degradation of the image wh... Class II Verathon, Inc.
Apr 29, 2024 BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... Due to software issue the device may give false "SpO2 Probe Failure" alarm Class II Nihon Kohden America Inc
Apr 24, 2024 Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)... The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... Class II Lucid Diagnostics, Inc.
Apr 24, 2024 Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)... The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... Class II Lucid Diagnostics, Inc.
Apr 22, 2024 ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 806592... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
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 ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research 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.