Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2021 | Simpleware ScanIP software. For transfer of imaging information from a medica... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| May 27, 2021 | ARTIS pheno- angiography systems developed for single and biplane diagnostic ... | Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... | Class II | Siemens Medical Solutions USA, Inc |
| May 26, 2021 | Azurion systems with software release R1.x | In the Azurion system, the user can add a new study to a patient by selecting the option Add St... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 26, 2021 | Azurion systems with software release R2.0.x | In the Azurion system, the user can add a new study to a patient by selecting the option "Add Stu... | Class II | Philips Healthcare |
| May 19, 2021 | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imagin... | The firm is aware of a issue with ultrasound software that results in unintended video frames b... | Class II | Caption Health |
| May 19, 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Reports received of NO measured below desired dose during transition between primary console and ... | Class I | Vero Biotech, LLC |
| May 18, 2021 | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... | ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 14, 2021 | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Ins... | Display of potential patient movement might be delayed to the user for high dose treatments. | Class II | Brainlab AG |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 4, 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product ... | Software anomalies affecting the French, German and Italian versions of treatment delivery system... | Class II | Viewray, Inc. |
| Apr 30, 2021 | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Apr 28, 2021 | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R | An issue was identified where the software froze during processing of commands, which resulted in... | Class II | Randox Laboratories Ltd. |
| Apr 26, 2021 | Concerto User Interface Software provided with the following systems: (1) ... | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not u... | Class II | Xstrahl Limited |
| Apr 20, 2021 | Multitom RAX with software version VF10 | Siemens identified two issues, In some cases, it is possible to perform an image acquisition alth... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 19, 2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... | A software defect was identified where the Image Styles defined by presentation states from CHRS ... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 15, 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicros... | Examination data and patient name may be mixed up when printing or generating a pdf with the inte... | Class II | Haag-Streit USA Inc |
| Apr 8, 2021 | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalo... | Emergency Use Application (EUA) application withdrawn as false negative results reported | Class II | Meridian Bioscience Inc |
| Apr 7, 2021 | RayStation standalone software radiation therapy treatment planning system. ... | When using more than one plan in a treatment course, the Total dose display in Dose tracking ma... | Class II | RAYSEARCH LABORATORIES AB |
| Apr 6, 2021 | CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Mar 31, 2021 | SoftCytogenetics | Software is given wrong results going out to HIS on test that had reruns. | Class II | Soft Computer Consultants, Inc. |
| Mar 31, 2021 | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 31, 2021 | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 31, 2021 | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and in... | Software showing wrong results reported, PDF not match HIS. | Class II | Soft Computer Consultants, Inc. |
| Mar 31, 2021 | AM12M Acquisition Module accessory. Impacted software version of the AM12M i... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 31, 2021 | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 29, 2021 | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... | Class II | Philips North America Llc |
| Mar 22, 2021 | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... | Class III | Datascope Corp. |
| Mar 22, 2021 | Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... | There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... | Class III | Datascope Corp. |
| Mar 22, 2021 | Normand Remisol Advance Data Manager is a software device that interfaces bet... | Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions reg... | Class II | Normand-Info S.A.S.U. |
| Mar 19, 2021 | Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTI... | Siemens has become aware of a potential issue with software version VE20C. Planned procedures may... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 17, 2021 | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1... | Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Ma... | Class II | SIGHT DIAGNOSTICS LTD |
| Mar 17, 2021 | Change Healthcare Enterprise Viewer | Change Healthcare has identified an intermittent software defect which may result in an anchor st... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Mar 15, 2021 | MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU... | Due to a software design issue, under certain conditions, a software fault is detected when a lar... | Class II | Medtronic Minimed |
| Mar 15, 2021 | MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ... | Due to a software design issue, under certain conditions, a software fault is detected when a lar... | Class II | Medtronic Minimed |
| Mar 9, 2021 | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr... | There are two issues within this correction action: 1. Cycling Issue: When copying settings fro... | Class II | Medtronic Neuromodulation |
| Mar 5, 2021 | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematolog... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology a... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematol... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematolo... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, aut... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare 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.