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 |
|---|---|---|---|---|
| Dec 2, 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ... | Class II | Cyberonics, Inc |
| Nov 22, 2017 | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... | Class II | Smiths Medical ASD Inc. |
| Nov 21, 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... | The device software versions have an anomaly which may produce an erroneous marking for the quali... | Class II | Oculus Optikgeraete GMBH |
| Nov 20, 2017 | Phadia Prime software, article number 12-4101-00, as used in combination with... | We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ... | Class II | Phadia Ab |
| Nov 20, 2017 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... | When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product that include both f... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 15, 2017 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 14, 2017 | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and in... | Due to a software error, it was observed that when the user closes the access door, the system wi... | Class II | Carl Zeiss Metrology Inc |
| Nov 13, 2017 | VNS Therapy Programmer, Model 3000, v1.0 System | Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo... | Class II | Cyberonics, Inc |
| Nov 8, 2017 | SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1... | When an error message remains displayed and is not cleared in the Protura software with the Elekt... | Class II | Med Tec Inc |
| Nov 8, 2017 | SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic sy... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 7, 2017 | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 16, 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Oct 16, 2017 | Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remi... | Beckman Coulter has identified that due to a software nonconformity in connection with a changed ... | Class II | Normand Informatique |
| Oct 11, 2017 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... | Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... | Class I | Spacelabs Healthcare, Ltd. |
| Oct 10, 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... | Class II | Medtronic Inc. |
| Oct 6, 2017 | Philips Ingenuity Core 128 computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Ingenuity CT computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Ingenuity Core computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 6, 2017 | Philips Brilliance 64 computed tomography x-ray system | Numerous issues related to software Brilliance iCT 4.1.6 software version. | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 5, 2017 | 2008T, Hemodialysis Delivery System Product Indicated for acute and chroni... | While reviewing documentation for the next software release of the 2008T, an R&D technician ident... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 28, 2017 | V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... | Class II | Steris Corporation |
| Sep 25, 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the v... | The observed issues can lead to unexpected interruptions of the optics carrier focus drive moveme... | Class II | Leica Microsystems, Inc. |
| Sep 12, 2017 | i-STAT DE handheld data processing module for clinical use, Software Version ... | Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis... | Class II | Abbott Point Of Care Inc. |
| Sep 5, 2017 | Patient Positioning System with KRC2 controller using software versions 2.3.1... | Communications between the Patient Positioning System and the accuracy filter can periodically fa... | Class II | Forte Automation Systems Inc |
| Aug 31, 2017 | Syngo.via systems with SW VB20A | A software update was released on August 22, 2017. Performing this software installation and upgr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the phys... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 18, 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software v... | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostat... | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Pro... | Class II | Edap Technomed Inc. |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is... | Incorrect source step size may occur in the software plans | Class II | Nucletron BV |
| Aug 7, 2017 | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 4, 2017 | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspir... | FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... | Class II | Fujifilm Medical Systems U.S.A., 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.