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 |
|---|---|---|---|---|
| Feb 18, 2013 | Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 1... | A software defect was discovered that causes images to be out of context with clinical information. | Class II | Ge Healthcare It |
| Feb 15, 2013 | Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brillian... | This field change order is being released to update software and customer release notes to the af... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 15, 2013 | RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... | Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 15, 2013 | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... | Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Feb 12, 2013 | Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel... | Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 8, 2013 | GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ... | GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us... | Class II | GE Healthcare, LLC |
| Feb 6, 2013 | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The P... | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... | Class II | Hospira Inc. |
| Feb 6, 2013 | Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The ... | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... | Class II | Hospira Inc. |
| Feb 6, 2013 | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The P... | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... | Class II | Hospira Inc. |
| Feb 5, 2013 | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) an... | Vital Images has found a potential error in measurement generated through the software which aff... | Class II | Vital Images, Inc. |
| Feb 5, 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... | Observed instability of the device. | Class II | Zimmer Biomet, Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion System is a cassette based multifunction infusion system... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+3 Infusion System is a cassette based multifunction infusion syste... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infu... | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... | Class II | Hospira Inc. |
| Jan 31, 2013 | Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. ... | Hitachi discovered a software error that can occur when simultaneously scanning a patient while p... | Class II | Hitachi Medical Systems America Inc |
| Jan 17, 2013 | SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Pa... | Siemens became aware of a potential safety issue when using the "In-session resumption" feature o... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 9, 2013 | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the ... | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, par... | Class II | Envoy Medical Corporation |
| Dec 28, 2012 | CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: ... | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... | Class II | Veridex, LLC |
| Dec 28, 2012 | CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usag... | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... | Class II | Veridex, LLC |
| Dec 21, 2012 | nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... | There is an error related to the relative geometry between fiber tracts in a fiber group and imag... | Class II | NordicNeuroLab AS |
| Dec 20, 2012 | Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emis... | Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 19, 2012 | HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMIL... | Analysis of a customer complaint has shown that during ventilation of small pediatric patients wi... | Class I | Hamilton Medical Inc |
| Dec 16, 2012 | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCa... | Care Innovations detected a software anomaly: During the engineering investigation into the cause... | Class II | Intel-GE Care Innovations LLC |
| Dec 10, 2012 | Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning... | Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu... | Class II | Integra LifeSciences Corp. |
| Dec 7, 2012 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ... | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... | Class II | Hospira Inc. |
| Dec 7, 2012 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;... | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... | Class II | Hospira Inc. |
| Dec 4, 2012 | Abbott m2000sp Instrument; an automated fluid handling system for performing ... | An issue with the m2000sp Instrument software has been identified whereby, after a series of step... | Class II | Abbott Molecular |
| Dec 3, 2012 | Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: B... | Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0x... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 28, 2012 | Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry an... | Due to a software data storage limitation which only occurs under certain conditions, measurement... | Class II | Beckman Coulter Inc. |
| Nov 28, 2012 | COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. | The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being u... | Class II | Roche Molecular Systems, Inc. |
| Nov 28, 2012 | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack.... | Mindray has identified a software anomaly that may where, in the presence of an asystole, the Tel... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Nov 27, 2012 | Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syn... | Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" func... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 26, 2012 | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 i... | In the course of the firm's product monitoring activities, a potential risk for patient or operat... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different value... | Class II | GE Healthcare It |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... | Class III | GE Healthcare It |
| Nov 20, 2012 | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... | Class II | GE Healthcare It |
| Nov 19, 2012 | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic ana... | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener ... | Class III | Roche Diagnostics Operations, Inc. |
| Nov 16, 2012 | Centricity Enterprise Archive is a software product for receiving, archiving ... | There is a potential for data loss associated with empty path names resulting from HL-7 updates w... | Class II | Ge Healthcare It |
| Nov 14, 2012 | Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system ... | Due to a problem with the control software of the x-ray high-voltage generator, if scanning is pe... | Class II | Toshiba American Medical Systems Inc |
| Nov 9, 2012 | Philips IntelliVue Information Center/Client and Philips IntelliVue Informati... | Internal audio cable may have diminished retention force due to damaged contacts, which could lea... | Class II | Philips Healthcare Inc. |
| Nov 8, 2012 | Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system... | Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option ... | Class II | Toshiba American Medical Systems Inc |
| Nov 1, 2012 | CADstream software. Product Usage: CADstream is an image processing syst... | An incorrect biopsy or missed target could result if the incorrect grid is selected within the ap... | Class II | Merge Healthcare, Inc. |
| Oct 30, 2012 | Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... | With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in ... | Class II | Philips Healthcare Inc. |
| Oct 26, 2012 | Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Conn... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira Inc. |
| Oct 26, 2012 | Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira 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.