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 |
|---|---|---|---|---|
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, 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, 3D B.40 ZIP-ML 02, 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-ML05, 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 I ZIP-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, B.40, 3D I USB-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-ML04, 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, 3D B.40 USB-ML05, 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 IND USB-ML 02, 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, B.40 Dualt-ML, Industry instrument softw... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 11, 2012 | COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... | Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection... | Class II | Roche Molecular Systems, Inc. |
| Oct 9, 2012 | Digital RID Plate Reader and Software Product Code: AD400 | If a control ring is marked after reading, the software will not flag results that are out of the... | Class II | The Binding Site Group, Ltd. |
| Oct 5, 2012 | Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), ... | Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection softwa... | Class II | Philips Medical Systems (Cleveland), Inc. |
| Oct 2, 2012 | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... | Class II | GE Healthcare It |
| Sep 28, 2012 | Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... | Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 28, 2012 | Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... | Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 21, 2012 | Diamigo i-Phone App The Diamigo app was intended for use as an educationa... | Diamigo, a software application, was released through the i-Phone Global Store which inadvertentl... | Class II | sanofi-aventis US, Inc. |
| Sep 20, 2012 | ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 | Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTR... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4... | InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ... | Class II | Hologic, Inc. |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an... | Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b... | Class II | Hologic, Inc. |
| Sep 12, 2012 | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten... | MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software ... | Class II | Mako Surgical Corporation |
| Sep 11, 2012 | Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... | Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 3, 2012 | UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel... | Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment proce... | Class II | Beckman Coulter Inc. |
| Aug 28, 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... | Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... | Class III | Philips Medical Systems (Cleveland) Inc |
| Aug 24, 2012 | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Versio... | The display on the system has the potential to change. In house testing eventually identified the... | Class II | Volcano Corporation |
| Aug 21, 2012 | Oncentra External Beam 4.1. Radiation treatment planning software designed... | During the planning process the beam weights can be changed by the customers. When the beam weigh... | Class II | Elekta, Inc. |
| Aug 17, 2012 | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device... | The firm recalled the device after learning of a possible deviation in the stimulus luminance of ... | Class II | Haag-Streit USA Inc |
| Aug 16, 2012 | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... | Shipped with incorrect software | Class II | ZOLL Medical Corporation |
| Aug 16, 2012 | GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst... | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21... | Class II | GE Healthcare, LLC |
| Aug 13, 2012 | GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ... | GE Healthcare became aware of a potential issue related to incorrect image measurement associated... | Class II | GE Healthcare, LLC |
| Aug 13, 2012 | Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC... | Vital Images has found two potential errors in calcium score values in restored snapshots of stud... | Class II | Vital Images, Inc. |
| Aug 8, 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 3, 2012 | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System | GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Mode... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Jul 30, 2012 | DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 throu... | A condition can occur during renumbering of the patient database using the DEXCopy feature. When... | Class II | Imaging Sciences International, LLC |
| Jul 24, 2012 | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended ... | Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22,... | Class II | Capintec Inc |
| Jul 23, 2012 | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys... | Review of instrument software databases and investigation of two customer reports determined that... | Class III | Trek Diagnostic Systems |
| Jul 23, 2012 | Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.... | Software anomaly may result in incorrect values and interpretations. The initial vital signs read... | Class II | Cisco Systems Inc |
| Jul 18, 2012 | The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... | 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 16, 2012 | DataCara GM is an information management system that provides data management... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The COBAS 8000 data manager modular analyzer series (all versions) is a is a... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | Data Station AMPLILINK software is an instrument user interface/ data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, Inc. |
| Jul 16, 2012 | DataCare POC is an information management system that provides data managem... | Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | Class II | Roche Molecular Systems, 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.