Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 24, 2012 | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended ... | Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22,... | Class II | Capintec Inc |
| Jul 23, 2012 | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys... | Review of instrument software databases and investigation of two customer reports determined that... | Class III | Trek Diagnostic Systems |
| Jul 23, 2012 | Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.... | Software anomaly may result in incorrect values and interpretations. The initial vital signs read... | Class II | Cisco Systems Inc |
| Jul 18, 2012 | The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... | 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 16, 2012 | DataCara GM is an information management system that provides data management... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The COBAS 8000 data manager modular analyzer series (all versions) is a is a... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | Data Station AMPLILINK software is an instrument user interface/ data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataCare POC is an information management system that provides data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 12, 2012 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... | GE Healthcare has recently become aware of a number of potential issues associated with the CARE... | Class II | GE Healthcare, LLC |
| Jul 11, 2012 | Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... | Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could ... | Class II | Philips Healthcare Inc. |
| Jul 11, 2012 | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model ... | In certain situations, loss of post exercise images can occur in Stress Echo. | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 10, 2012 | Optima XR200amx. Mobile general purpose radiographic imaging of the human he... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| Jul 10, 2012 | Optima XR220amx Mobile general purpose radiographic imaging of the human h... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are inte... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyze... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 2, 2012 | Varian brand Varian ARIA Oncology Information System, Import Export applicat... | A software anomaly has been identified with the Import Export Application version 11.0 where MLC... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| Jul 2, 2012 | Merge HEMO software. | The International Normalized Ratio (INR) value displayed in the study report does not match the v... | Class II | Merge Healthcare, Inc. |
| Jun 29, 2012 | BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS... | Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. | Class II | BD Biosciences, Systems & Reagents |
| Jun 28, 2012 | GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar... | GE Healthcare has recently become aware of a potential safety issue with respect to the Results V... | Class II | GE Healthcare, LLC |
| Jun 20, 2012 | Siemens syngo.plaza Radiological Image Processing System Usage: Radiologic... | Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instr... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 20, 2012 | Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... | Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG | Class II | Philips Healthcare Inc. |
| Jun 18, 2012 | superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicate... | superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software... | Class II | superDimension, Inc |
| Jun 15, 2012 | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled... | Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR... | Class II | Hitachi Medical Systems America Inc |
| Jun 14, 2012 | Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... | Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface | Class II | Philips Healthcare Inc. |
| Jun 6, 2012 | ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - ... | The firm recalled because the glucose measurements from a patient sample that the customer felt w... | Class II | Sendx Medical Inc |
| May 29, 2012 | Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... | GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... | Class II | GE Healthcare, LLC |
| May 24, 2012 | GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.... | GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o... | Class II | GE Healthcare, LLC |
| May 24, 2012 | GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an... | GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv... | Class II | GE Healthcare, LLC |
| May 24, 2012 | GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View... | GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT... | Class II | GE Healthcare, LLC |
| May 23, 2012 | Intellispace Portal software. Intellispace Portal is a multimodality thin ... | Philips is issuing a software update to the Intellispace Portal systems to address a number of no... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 23, 2012 | IntelliSpace Portal software and Extended Brillance Workspace software In... | The Intellispace Portal software and Extended Brillance Workspace software may have significantly... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 22, 2012 | CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 66070... | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... | Class II | Beckman Coulter Inc. |
| May 22, 2012 | Intellispace Portal software Product Usage: Intellispace Portal is a mult... | In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using ... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 22, 2012 | Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... | With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirro... | Class II | Philips Healthcare Inc. |
| May 22, 2012 | TetraCXP Software System, Part Number A40051. Allows simultaneous identifi... | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... | Class II | Beckman Coulter Inc. |
| May 22, 2012 | CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.... | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... | Class II | Beckman Coulter Inc. |
| May 21, 2012 | Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... | Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure... | Class II | Natus Medical Incorporated |
| May 21, 2012 | VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi ... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | Class II | Ortho-Clinical Diagnostics |
| May 21, 2012 | VITROS 4600 Chemistry System Software For use in the in-vitro quantitativ... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | Class II | Ortho-Clinical Diagnostics |
| May 21, 2012 | VITROS 5600 Integrated System Software For use in the in-vitro quantitati... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | Class II | Ortho-Clinical Diagnostics |
| May 11, 2012 | ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, V... | In some cases, the system is unable to capture a clip or image during a routine scan. | Class II | Siemens Medical Solutions USA, Inc. |
| May 11, 2012 | The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... | The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter ... | Class II | Spacelabs Healthcare, Llc |
| May 9, 2012 | Brand name: RayStation. Generic name: Treatment Planning System. Software ... | The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, R... | Class II | RAYSEARCH LABORATORIES AB |
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.