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 |
|---|---|---|---|---|
| Jun 4, 2014 | ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... | Software corrections reactivating the cooperative endoscopy mode. | Class II | Zimmer Biomet, Inc. |
| Jun 3, 2014 | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30... | There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 3, 2014 | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201... | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may un... | Class II | Nihon Kohden America Inc |
| May 29, 2014 | iGUIDE System Product Usage: The intended use of the device is the contro... | A bug in the software prevents the iGUIDE software from logging off. | Class II | Elekta, Inc. |
| May 28, 2014 | Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculati... | Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1,... | Class II | Baxter Corporation Englewood |
| May 28, 2014 | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 00... | Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Car... | Class II | Shape Medical Systems, Inc |
| May 22, 2014 | IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I... | IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume... | Class II | Philips Medical Systems, Inc. |
| May 21, 2014 | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... | Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intra... | Class II | Brainlab AG |
| May 15, 2014 | Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use o... | An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2014 | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... | Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simpl... | Class II | Focus Diagnostics Inc |
| May 13, 2014 | The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 9, 2014 | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP100... | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK... | Class II | Physio-Control, Inc. |
| May 8, 2014 | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia De... | A software anomaly causes temperature alarm limits to change to limits which are not physiologica... | Class II | Spacelabs Healthcare Inc |
| May 6, 2014 | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L... | There is a potential risk when using LANTIS OIS System client software with operating systems for... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2014 | Horizon Medical Imaging It is a medical image and information management a... | The firm has identified a software issue which may cause a discrepancy between the index of image... | Class II | Mckesson Medical Immaging |
| May 5, 2014 | All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... | In spine clinical workflows, cross reference lines may be used to determine the position of slice... | Class II | Philips Medical Systems, Inc. |
| Apr 30, 2014 | Merge Hemo software. Merge Hemo monitors, measures, and records physiolog... | The application may crash during the cath lab procedure. | Class II | Merge Healthcare, Inc. |
| Apr 30, 2014 | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optic... | Failure to effectively install and test a hotfix to correct the known software defect within the ... | Class II | AGFA Corp. |
| Apr 25, 2014 | RayStation software version 4.0.3.4 RayStation is a software system design... | This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... | Class II | RAYSEARCH LABORATORIES AB |
| Apr 23, 2014 | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... | CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... | Class I | CareFusion 303, Inc. |
| Apr 23, 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using S... | Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasoun... | Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 22, 2014 | HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anes... | Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the ac... | Class I | Hamilton Medical, Inc. |
| Apr 17, 2014 | enGen (TM) Laboratory Automation System Configured with TCAutomation" Softwar... | Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Sys... | Class II | Ortho-Clinical Diagnostics |
| Apr 10, 2014 | enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vit... | Software anomaly: potential for delay in the reporting of patient sample test results when using ... | Class II | Ortho-Clinical Diagnostics |
| Apr 7, 2014 | GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 ... | GE Healthcare has recently become aware of a potential safety issue due to higher than actual flo... | Class II | GE Healthcare, LLC |
| Apr 3, 2014 | iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... | Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... | Class II | Boston Scientific Corporation |
| 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 |
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.