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 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 |
| May 9, 2012 | The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... | The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... | Class I | Natus Medical Incorporated |
| May 7, 2012 | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... | Mindray has identified two software anomalies contained in the V Series Monitoring System. There... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| May 7, 2012 | The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended ... | Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems cur... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 4, 2012 | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is... | Hitachi discovered a software error in the Reconstruction Status function that creates a potentia... | Class II | Hitachi Medical Systems America Inc |
| Apr 23, 2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P... | Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG... | Class III | Sigma |
| Apr 23, 2012 | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... | When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK softw... | Class II | Roche Molecular Systems, Inc. |
| Apr 19, 2012 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | Potential failure of the optical distance sensor due to cable disconnection. | Class II | Zimmer Biomet, Inc. |
| Apr 19, 2012 | The GE Centricity Web; Software Version 3.0x, is intended for use under the d... | GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... | Class II | Ge Healthcare It |
| Apr 11, 2012 | AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The A... | The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tube... | Class II | Beckman Coulter Inc. |
| Apr 4, 2012 | GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (A... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Mar 27, 2012 | GE Healthcare, Advantage Workstation, READY View Application. Image analys... | GE Healthcare has become aware that when analyzing fMRI images using the READY View application s... | Class II | GE Healthcare, LLC |
| Mar 23, 2012 | Infusomat(R) Space Pump (US Version) with software version 686G030103 (common... | Firm became aware of the potential for breakage of the anti free flow clip catch, located on the ... | Class I | B. Braun Medical, Inc. |
| Mar 15, 2012 | Sunquest Laboratory Sunquest Laboratory is intended for use by professiona... | Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, ... | Class II | Sunquest Information Systems, Inc. |
| Feb 24, 2012 | Siemens syngo.plaza. Radiological image processing system | Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20... | Class II | Siemens Medical Solutions USA, 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.