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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 13, 2024 | Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 11, 2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... | System error messages may delay the ability to test patient samples and the need for frequent cal... | Class II | Advanced Instruments, LLC |
| Mar 7, 2024 | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... | Class I | Fresenius Kabi USA, LLC |
| Feb 28, 2024 | Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 28, 2024 | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 27, 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... | Class I | Smiths Medical ASD Inc. |
| Feb 23, 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Junipe... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 23, 2024 | ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running softw... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 8, 2024 | microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 11... | Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated thi... | Class II | Landauer |
| Feb 8, 2024 | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... | Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... | Class II | PTW-FREIBURG |
| Feb 7, 2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with I... | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems ex... | Class II | Life Technologies Corporation |
| Feb 1, 2024 | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... | Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... | Class II | CareFusion 303, Inc. |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
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.