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.

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DateProductReasonClassFirm
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.
Oct 25, 2012 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... When the operator for a wall stand view selects an "image rotation" different from default, or su... Class II Philips Healthcare Inc.
Oct 24, 2012 Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... When the MC-500 is turned on and coagulation is performed without changing the laser color, the d... Class II Nidek Inc
Oct 24, 2012 Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument T... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, ... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrumen... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instr... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB up... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, US... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux 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.