Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 14, 2014 | RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alon... | RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software d... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 14, 2014 | ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... | An undetected shift between the information displayed in the navigation software and the actual p... | Class II | Zimmer Biomet, Inc. |
| Feb 14, 2014 | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... | HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Feb 13, 2014 | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... | GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... | Class II | GE Healthcare, LLC |
| Feb 12, 2014 | CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... | Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... | Class II | Biosense Webster, Inc. |
| Feb 11, 2014 | Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. | Philips Medical Systems have recently determined that a software nonconformance can cause incorre... | Class II | Philips Medical Systems (Cleveland), Inc. |
| Feb 6, 2014 | RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 ... | Potential for dose errors due to software program errors. | Class II | RAYSEARCH LABORATORIES AB |
| Feb 6, 2014 | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alo... | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 24, 2014 | RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medic... | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6... | Class II | Clarity Medical Systems Inc |
| Jan 20, 2014 | GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital ... | GE Healthcare has recently become aware of a software issue associated with patient selection fro... | Class II | GE Healthcare, LLC |
| Jan 8, 2014 | CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRAC... | Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. | Class II | Veridex, LLC |
| Dec 27, 2013 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARES... | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... | Class II | GE Healthcare, LLC |
| Dec 26, 2013 | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by... | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software ... | Class II | Carestream Health, Inc. |
| Dec 20, 2013 | CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intende... | There is a potential for communication loss associated with the F5-01 Frame when connected to CAR... | Class II | GE Healthcare, LLC |
| Dec 18, 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | Possible break in the connector of the Force Sensor. | Class II | Zimmer Biomet, Inc. |
| Dec 16, 2013 | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... | Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst... | Class I | Covidien |
| Dec 11, 2013 | GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova... | GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno... | Class II | GE Healthcare, LLC |
| Dec 4, 2013 | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio... | Class II | Ion Beam Applications S.A. |
| Dec 3, 2013 | ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... | Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... | Class II | Baxter Corporation Englewood |
| Nov 29, 2013 | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process... | Error copying information to the clinical file and to the report when two 3D models are opened si... | Class II | EOS Imaging |
| Nov 25, 2013 | MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio... | This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 25, 2013 | Agility. Version 3.1 of the Integrity interface and control software for the... | During the treatment table, gantry, and collimator calibration procedures, it is possible to type... | Class II | Elekta, Inc. |
| Nov 25, 2013 | Integrity. Version 1.1 of the Integrity interface and control software for t... | During the treatment table, gantry, and collimator calibration procedures, it is possible to type... | Class II | Elekta, Inc. |
| Nov 25, 2013 | Desktop Pro TM linear accelerator control software intended to assist a licen... | During the treatment table, gantry, and collimator calibration procedures, it is possible to type... | Class II | Elekta, Inc. |
| Nov 25, 2013 | Agility. Version 3.0 of the Integrity interface and control software for the... | During the treatment table, gantry, and collimator calibration procedures, it is possible to type... | Class II | Elekta, Inc. |
| Nov 21, 2013 | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. ... | Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 80... | Class II | Welch Allyn Protocol, Inc |
| Nov 18, 2013 | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... | The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ... | Class II | Brainlab AG |
| Nov 18, 2013 | Plan Parameters workspace within Eclipse Treatment Planning System Version 1... | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a ... | Class II | Varian Medical Systems, Inc. |
| Nov 15, 2013 | Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition ... | During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM D... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 7, 2013 | GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... | There exists a software issue associated with patient selection from the worklist on the Optima X... | Class II | GE Healthcare, LLC |
| Nov 6, 2013 | Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Us... | The ADVIA Chemistry software systems using certain software versions allows the system to automat... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 6, 2013 | Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-10... | When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software vers... | Class II | Data Innovations, Inc. |
| Oct 30, 2013 | Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The... | Under extremely rare circumstances, a patient result that had been previously disabled may be rel... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 30, 2013 | Easy Diagnost Eleva Universal Fluoroscopic applications | The delivered application software was an outdated version to the model of equipment. | Class II | Philips Medical Systems, Inc. |
| Oct 25, 2013 | ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva C... | There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when th... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 24, 2013 | Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, an... | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when u... | Class II | Nobel Biocare Usa Llc |
| Oct 21, 2013 | VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3... | Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a... | Class II | Vital Images, Inc. |
| Oct 17, 2013 | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagn... | A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and... | Class II | Philips Medical Systems North America Inc. |
| Oct 14, 2013 | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... | Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... | Class II | Philips Healthcare Informatics, Inc. |
| Oct 11, 2013 | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... | GE became aware of a potential safety issue due to a system slow down and system lock up associat... | Class II | GE Healthcare, LLC |
| Oct 10, 2013 | VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... | Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... | Class II | Ortho-Clinical Diagnostics |
| Oct 9, 2013 | Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX | NT2000iX software shipped with the international setting turned on. The international settings in... | Class II | Neurotherm, Inc. |
| Oct 7, 2013 | 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... | In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... | Class II | Baxter Healthcare Corp. |
| Oct 7, 2013 | CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP iso... | Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso ... | Class II | LAP of America Laser Applications, LLC |
| Oct 7, 2013 | User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension ... | When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the syste... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 1, 2013 | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ... | There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio... | Class II | Omnyx Llc |
| Oct 1, 2013 | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil... | Toshiba intitiated this recall because their investigation revealed that due to a problem of the ... | Class II | Toshiba American Medical Systems Inc |
| Sep 20, 2013 | The Vantage Digital Panoramic System delivers high-value features standard on... | An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.... | Class II | Midmark Corp dba Progeny Inc |
| Sep 19, 2013 | AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH... | GE Healthcare has recently become aware of a potential safety issue due to the image orientation ... | Class II | GE Healthcare, LLC |
| Sep 19, 2013 | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Arch... | System downtime and/or slow performance may result if software in use is an old version of IMPAX ... | Class II | AGFA Corp. |
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.