Browse Device Recalls
2,945 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,945 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 2,945 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 22, 2024 | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.2mm 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 |
| 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 |
| Apr 19, 2024 | Patient Information Center iX and Patient Information Center iX Expand, Softw... | Event Catalog information does not save when copied and transferred from one unit to another. | Class II | Philips North America Llc |
| Apr 18, 2024 | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... | When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... | Class II | Beckman Coulter, Inc. |
| Apr 18, 2024 | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... | Class II | Beckman Coulter, Inc. |
| Apr 16, 2024 | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Rad... | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. | Class II | Reflexion Medical, Inc. |
| Apr 16, 2024 | Stryker Blueprint Software, Catalog #BPUE001. | The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented impla... | Class II | Tornier S.A.S. |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 5, 2024 | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative ... | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that... | Class III | Randox Laboratories Ltd. |
| Apr 4, 2024 | Philips IntelliSpace Cardiovascular software, Model 830089. | Study data is not able to be archived, copied, or exported with the cardiovascular software version. | Class II | Philips Medical Systems Nederland B.V. |
| Apr 4, 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... | Unreleased software was installed on customer systems resulting in the visual feedback on the scr... | Class II | Stryker Leibinger GmbH & Co. KG |
| Apr 2, 2024 | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStai... | There is the potential for the front plexiglass door of the automated slide processing system to ... | Class II | Agilent Technologies |
| Mar 29, 2024 | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 29, 2024 | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A ... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 26, 2024 | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... | Class I | Medtronic Navigation, Inc. |
| Mar 25, 2024 | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... | Class I | SonarMed Inc |
| Mar 19, 2024 | Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 13, 2024 | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Numbe... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
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.