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 |
|---|---|---|---|---|
| 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. |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | 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 XT 3400 Chemistry System, Catalog No. 6844458 | 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 XT 7600 Integrated System, Catalog No. 6844461 | 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 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 3, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... | A software error caused an increase in tray gripper motion errors that causes intermittent hard s... | Class II | Beckman Coulter, Inc. |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 22, 2023 | Baxter Exactamix Pro 2400, REF EXM24DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 22, 2023 | Baxter Exactamix Pro 1200, REF EXM12DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2023 | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... | Class II | Zyno Medical LLC |
| Dec 19, 2023 | smiths medical Medfusion Model 4000 syringe pump | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... | Class I | Smiths Medical ASD Inc. |
| Dec 19, 2023 | smiths medical Medfusion Model 3500 Syringe pump | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... | Class I | Smiths Medical ASD Inc. |
| Dec 13, 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 13, 2023 | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 8, 2023 | WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Deskto... | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system co... | Class II | WAVi Co. |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 6, 2023 | Impella Connect, software portal for online device management that allows cli... | The following features have been disabled from the web-based portal because the FDA has not evalu... | Class II | Abiomed, Inc. |
| Nov 30, 2023 | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Multiple software issues that affect device functionality. | Class II | Philips North America Llc |
| Nov 30, 2023 | Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... | The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... | Class II | Boston Scientific Corporation |
| Nov 30, 2023 | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... | The bolus calculator is not recording the decimal point if it is the first value entered when cha... | Class I | Insulet Corporation |
| Nov 21, 2023 | DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, | There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... | Class II | Beckman Coulter, Inc. |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... | Class II | Covidien |
| Nov 15, 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopi... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 1, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... | Class II | Turncare, Inc |
| Oct 19, 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH 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.