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 |
|---|---|---|---|---|
| Jan 24, 2018 | DynaCad software consist of an MR Analysis Server software and the viewer wor... | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not... | Class II | Invivo Corporation |
| Jan 23, 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... | Missing desiccant. | Class II | Biomerieux Inc |
| Jan 17, 2018 | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version... | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Ce... | Class II | Spacelabs Healthcare Inc |
| Jan 12, 2018 | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 12, 2018 | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 11, 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jan 11, 2018 | IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Comput... | 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues inc... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 10, 2018 | Syngo.via software is intended to be used for viewing, manipulation, communic... | When the archiving configuration is changed, data received/created after the upgrade may be flagg... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2018 | Syngo.via. Medical Device Software. Picture archiving and communications sys... | A software functionality in the report sections Findings Information and Summary of Measured F... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 3, 2018 | Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 ... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | Intellivue iX Information Center Software - All PIIC iX Surveillance stations... | Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable ... | Class II | Philips Electronics North America Corporation |
| Dec 14, 2017 | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial... | When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 13, 2017 | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401... | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted ... | Class II | Smith & Nephew, Inc. |
| Dec 11, 2017 | Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This d... | A software issue causes PET reconstructions to fail intermittently. It was determined that recons... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 8, 2017 | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Acc... | Due to a system controller software anomaly, the patient positioning deviation correction may not... | Class II | Hitachi Ltd., Medical System Operations Group |
| Dec 8, 2017 | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... | Potential for the display processor to experience an unexpected failure. | Class II | Datex-Ohmeda, Inc. |
| Dec 8, 2017 | Widefield OCT software feature for the Spectralis HRA+OCT and variants | FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefiel... | Class II | Heidelberg Engineering |
| Dec 6, 2017 | Health Harmony Mobile application software Product Usage: Care Innovatio... | It was discovered that in certain situations, including partial sessions and when taking adhoc me... | Class II | Intel-GE Care Innovations LLC |
| Dec 4, 2017 | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following pr... | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, a... | Class II | Cellavision AB |
| Dec 4, 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... | Class II | Beckman Coulter Inc. |
| Dec 2, 2017 | Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software versi... | Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusio... | Class II | Fresenius Vial Sa |
| Dec 2, 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ... | Class II | Cyberonics, Inc |
| Nov 22, 2017 | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... | Class II | Smiths Medical ASD Inc. |
| Nov 21, 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... | The device software versions have an anomaly which may produce an erroneous marking for the quali... | Class II | Oculus Optikgeraete GMBH |
| Nov 20, 2017 | Phadia Prime software, article number 12-4101-00, as used in combination with... | We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ... | Class II | Phadia Ab |
| Nov 20, 2017 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... | When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product that include both f... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 15, 2017 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 14, 2017 | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and in... | Due to a software error, it was observed that when the user closes the access door, the system wi... | Class II | Carl Zeiss Metrology Inc |
| Nov 13, 2017 | VNS Therapy Programmer, Model 3000, v1.0 System | Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo... | Class II | Cyberonics, Inc |
| Nov 8, 2017 | SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1... | When an error message remains displayed and is not cleared in the Protura software with the Elekt... | Class II | Med Tec Inc |
| Nov 8, 2017 | SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic sy... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 7, 2017 | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 16, 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Oct 16, 2017 | Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remi... | Beckman Coulter has identified that due to a software nonconformity in connection with a changed ... | Class II | Normand Informatique |
| Oct 11, 2017 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... | Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... | Class I | Spacelabs Healthcare, Ltd. |
| Oct 10, 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... | Class II | Medtronic Inc. |
| Oct 6, 2017 | Philips Ingenuity Core 128 computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Ingenuity CT computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Ingenuity Core computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Brilliance 64 computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 5, 2017 | 2008T, Hemodialysis Delivery System Product Indicated for acute and chroni... | While reviewing documentation for the next software release of the 2008T, an R&D technician ident... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 28, 2017 | V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... | Class II | Steris Corporation |
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.