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.

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DateProductReasonClassFirm
Dec 18, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Possible break in the connector of the Force Sensor. Class II Zimmer Biomet, Inc.
Dec 16, 2013 Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst... Class I Covidien
Dec 11, 2013 GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova... GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno... Class II GE Healthcare, LLC
Dec 4, 2013 Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio... Class II Ion Beam Applications S.A.
Dec 3, 2013 ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... Class II Baxter Corporation Englewood
Nov 29, 2013 steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process... Error copying information to the clinical file and to the report when two 3D models are opened si... Class II EOS Imaging
Nov 25, 2013 MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio... This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume... Class II Roche Diagnostics Operations, Inc.
Nov 25, 2013 Agility. Version 3.1 of the Integrity interface and control software for the... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 Integrity. Version 1.1 of the Integrity interface and control software for t... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 Desktop Pro TM linear accelerator control software intended to assist a licen... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 Agility. Version 3.0 of the Integrity interface and control software for the... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 21, 2013 The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. ... Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 80... Class II Welch Allyn Protocol, Inc
Nov 18, 2013 Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ... Class II Brainlab AG
Nov 18, 2013 Plan Parameters workspace within Eclipse Treatment Planning System Version 1... An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a ... Class II Varian Medical Systems, Inc.
Nov 15, 2013 Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition ... During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM D... Class II Siemens Medical Solutions USA, Inc
Nov 7, 2013 GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... There exists a software issue associated with patient selection from the worklist on the Optima X... Class II GE Healthcare, LLC
Nov 6, 2013 Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Us... The ADVIA Chemistry software systems using certain software versions allows the system to automat... Class II Siemens Healthcare Diagnostics, Inc.
Nov 6, 2013 Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-10... When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software vers... Class II Data Innovations, Inc.
Oct 30, 2013 Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The... Under extremely rare circumstances, a patient result that had been previously disabled may be rel... Class II Siemens Healthcare Diagnostics, Inc.
Oct 30, 2013 Easy Diagnost Eleva Universal Fluoroscopic applications The delivered application software was an outdated version to the model of equipment. Class II Philips Medical Systems, Inc.
Oct 25, 2013 ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva C... There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when th... Class II Roche Diagnostics Operations, Inc.
Oct 24, 2013 Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, an... The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when u... Class II Nobel Biocare Usa Llc
Oct 21, 2013 VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3... Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a... Class II Vital Images, Inc.
Oct 17, 2013 EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagn... A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and... Class II Philips Medical Systems North America Inc.
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... Class II Philips Healthcare Informatics, Inc.
Oct 11, 2013 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... GE became aware of a potential safety issue due to a system slow down and system lock up associat... Class II GE Healthcare, LLC
Oct 10, 2013 VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... Class II Ortho-Clinical Diagnostics
Oct 9, 2013 Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX NT2000iX software shipped with the international setting turned on. The international settings in... Class II Neurotherm, Inc.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Oct 7, 2013 CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP iso... Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso ... Class II LAP of America Laser Applications, LLC
Oct 7, 2013 User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension ... When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the syste... Class II Siemens Healthcare Diagnostics, Inc.
Oct 1, 2013 Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ... There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio... Class II Omnyx Llc
Oct 1, 2013 TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil... Toshiba intitiated this recall because their investigation revealed that due to a problem of the ... Class II Toshiba American Medical Systems Inc
Sep 20, 2013 The Vantage Digital Panoramic System delivers high-value features standard on... An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.... Class II Midmark Corp dba Progeny Inc
Sep 19, 2013 AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH... GE Healthcare has recently become aware of a potential safety issue due to the image orientation ... Class II GE Healthcare, LLC
Sep 19, 2013 IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Arch... System downtime and/or slow performance may result if software in use is an old version of IMPAX ... Class II AGFA Corp.
Sep 16, 2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PA... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM ... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers ... Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service A... Class II Roche Diagnostics Operations, Inc.
Sep 16, 2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS ... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS ... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PA... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health Inc.
Sep 16, 2013 Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS i... Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... Class II Carestream Health 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.