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 |
|---|---|---|---|---|
| Oct 11, 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2019 | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of... | Class II | Draegar Medical Systems, Inc. |
| Oct 7, 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT ... | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanne... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 4, 2019 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Sy... | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. | Class II | Neocis Inc. |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 1, 2019 | Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 25, 2019 | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MAN... | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Crani... | Class II | Brainlab AG |
| Sep 24, 2019 | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology in... | The user may inadvertently enter Metric values into Height and Weight fields labeled with US Stan... | Class II | Elekta Impac Software |
| Sep 24, 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 23, 2019 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and ... | The firm discovered a software issue associated with the Image-Com module/clinical application pa... | Class II | Tomtec Imaging Systems Gmbh |
| Sep 22, 2019 | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indica... | The navigated values displayed when using the LPI instrumentation are incorrect due to software i... | Class II | Blue Ortho |
| Sep 18, 2019 | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T7... | GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser... | Class II | GN Hearing A/S |
| Sep 18, 2019 | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP... | GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser... | Class II | GN Hearing A/S |
| Sep 18, 2019 | iLab Polaris Multi-Modality Guidance System; iLab Ultraso... | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc... | Class II | Boston Scientific Corporation |
| Sep 10, 2019 | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication... | The firm received a report of an atypical dataset being generated. When using the cross-localizat... | Class II | Novarad Corporation |
| Aug 29, 2019 | Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android sof... | The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging... | Class II | LABSTYLE INNOVATIONS |
| Aug 26, 2019 | Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, w... | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with th... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 23, 2019 | Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... | At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la... | Class II | Ra Medical Systems, Inc. |
| Aug 12, 2019 | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 12... | After a recent upgrade to the collimator software version 8.5, the firm became aware that the mul... | Class II | Varian Medical Systems, Inc. |
| Aug 9, 2019 | Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... | Class I | Medtronic Navigation, Inc. |
| Aug 6, 2019 | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors... | The device data being collected and transferred to the monitoring center may not be accurate due ... | Class II | Preventice Services, LLC |
| Jul 31, 2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 30, 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2019 | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing ... | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... | Class II | Becton Dickinson & Co. |
| Jul 26, 2019 | BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing ... | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m... | Class II | Becton Dickinson & Co. |
| Jul 25, 2019 | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog... | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 23, 2019 | AggreGuide A-100 Instrument | The firm identified a software design issue where the improper shut down of the instrument result... | Class II | Aggredyne, Inc. |
| Jul 23, 2019 | Mammomat Revelation with software version VC10 and Biopsy Option Intended ... | An error can occur when performing a biopsy using the InSpect function. The acquisition workstati... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 22, 2019 | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... | Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ... | Class II | Zeus Scientific, Inc. |
| Jul 18, 2019 | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Li... | Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (... | Class II | Medical Intelligence Medizintechnik Gmbh |
| Jul 16, 2019 | Philips Azurion systems with software version R1.2 -Interventional Fluorosc... | The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to t... | Class II | Philips North America, LLC |
| Jul 12, 2019 | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 ... | Class II | Dexcom Inc |
| Jul 12, 2019 | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... | Class II | ICU Medical, Inc. |
| Jul 10, 2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Software Security; The action is being initiated because of software security vulnerabilities wi... | Class II | Radiometer America 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.