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 |
|---|---|---|---|---|
| Apr 3, 2014 | Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PA... | Systems with the affected serial number are experiencing a software error which may lead to incor... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 2, 2014 | Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, ... | When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are use... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 2, 2014 | Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM pa... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared ... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controll... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... | 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... | Class I | Baxter Corporation Englewood |
| Apr 2, 2014 | Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... | Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ... | Class II | Philips Medical Systems, Inc. |
| Apr 2, 2014 | Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... | Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m... | Class II | Philips Medical Systems, Inc. |
| Apr 2, 2014 | Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrar... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Mar 27, 2014 | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... | An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... | Class II | INO Therapeutics (dba Ikaria) |
| Mar 20, 2014 | enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... | Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... | Class II | Ortho-Clinical Diagnostics |
| Mar 11, 2014 | IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... | During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 10, 2014 | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... | The System may go into a controlled failed state if a series of parameters on the user interface ... | Class I | Del Mar Reynolds Medical, Ltd. |
| Mar 6, 2014 | Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... | A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 5, 2014 | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used | Class II | ZOLL Medical Corporation |
| Feb 28, 2014 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 C... | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... | Class II | GE Healthcare, LLC |
| Feb 27, 2014 | Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by:... | On a rare occasion the D-10 software might generate an extra result by duplicating the result for... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 24, 2014 | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalog... | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might ... | Class II | Brainlab AG |
| Feb 14, 2014 | GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... | GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... | Class II | GE Healthcare, LLC |
| Feb 14, 2014 | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... | Class II | Spacelabs Healthcare, Llc |
| 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. |
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.