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 |
|---|---|---|---|---|
| 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 |
| Feb 17, 2012 | GE Healthcare Carescape Patient Data Module with v2.0 software used with Sola... | GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software ... | Class II | GE Healthcare, LLC |
| Feb 14, 2012 | Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... | Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... | Class I | Smiths Medical ASD, Inc. |
| Feb 12, 2012 | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee d... | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small... | Class II | Ossur Americas, Inc. |
| Feb 5, 2012 | *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 4, 2012 | "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corpora... | Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was upda... | Class II | Orthosensor |
| Nov 30, 2011 | TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to ... | The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) ... | Class II | Toshiba American Medical Systems Inc |
| Oct 19, 2011 | CADstream software Product Usage: CADstream is an image processing syst... | Customers may experience an issue with the software study preferences when changes are made to th... | Class II | Merge Healthcare, Inc. |
| Oct 13, 2011 | UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Nu... | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... | Class II | Beckman Coulter Inc. |
| Oct 13, 2011 | UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; D... | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... | Class II | Beckman Coulter Inc. |
| Oct 13, 2011 | UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; ... | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... | Class II | Beckman Coulter Inc. |
| Oct 10, 2011 | SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manu... | This notice concerns behavior of the SharePlan that may be unexpected and not clearly described i... | Class II | RAYSEARCH LABORATORIES AB |
| Oct 6, 2011 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Oct 6, 2011 | GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, pro... | GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used ... | Class II | GE Healthcare, LLC |
| Sep 1, 2011 | The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... | During a Field Test (a customer external evaluation period), the customer detected a problem in t... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 20, 2011 | GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas ... | GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 wh... | Class II | GE Healthcare, LLC |
| Jul 6, 2011 | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... | Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... | Class I | Baxter Healthcare Corporation |
| Jun 13, 2011 | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral f... | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer so... | Class II | Zyno Medical LLC |
| May 30, 2011 | The product affected by this notice is sold under the trade name TomoTherapy... | This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Off... | Class II | RAYSEARCH LABORATORIES AB |
| May 12, 2011 | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ... | There is a software anomaly with the DPM Central Monitoring System where the trend data of one pa... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Apr 5, 2011 | GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ra... | GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1... | Class II | GE Healthcare, LLC |
| Mar 3, 2011 | Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... | Multiple software defects which could impact the performance or reliability of the system. These... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 17, 2010 | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 8650... | Potential for early component failure. | Class II | Philips Electronics North America 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.