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 |
|---|---|---|---|---|
| Jul 9, 2014 | QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a softw... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 9, 2014 | QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a sof... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ... | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 7, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VIT... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative,... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 5, 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... | Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, t... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Jul 3, 2014 | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS i... | In specific situation a partially truncated file may be written to the IntelePACS server. This p... | Class II | Intelerad Medical Systems |
| Jul 1, 2014 | Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. ... | The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP ... | Class II | Ansar Group, Inc. Dba Ansar Medical Technologie... |
| Jun 27, 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... | Potential for demographic information and test result to be mismatch. | Class II | PerkinElmer Health Sciences, Inc. |
| Jun 27, 2014 | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Vi... | The following defects have been identified for data loaded with Patient Data Manager version 2.0 ... | Class II | Brainlab AG |
| Jun 18, 2014 | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.0... | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely... | Class II | Spacelabs Healthcare Inc |
| Jun 17, 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN... | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 13, 2014 | GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PD... | Class II | GE Healthcare, LLC |
| Jun 12, 2014 | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade ... | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in ... | Class II | Biolase Technology Inc |
| Jun 11, 2014 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... | Class I | GE Healthcare, LLC |
| Jun 10, 2014 | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... | If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... | Class II | Baxter Healthcare Corp. |
| Jun 6, 2014 | Philips Medical System Allura Xper X-Ray Angiographic | In certain circumstances, a software error can lead to a situation where the five minute fluorosc... | Class II | Philips Medical Systems, Inc. |
| Jun 6, 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg... | Class II | Hospira Inc. |
| Jun 5, 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | There is a potential problem with Artis zee and Artis zeego systems running software version VC21... | Class II | Siemens Medical Solutions USA, Inc |
| 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 |
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.