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 |
|---|---|---|---|---|
| May 15, 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Materia... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 12, 2020 | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 12, 2020 | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 12, 2020 | MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 8, 2020 | Merge Healthcare Merge Application Server Software Release and Merge Healthca... | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... | Class II | Merge Healthcare, Inc. |
| Apr 30, 2020 | Remisol Advance running Software Version 1.12 The Normand Info Remisol Adv... | Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and ... | Class II | Normand-Info S.A.S.U. |
| Apr 16, 2020 | Elekta MONACO RTP Sytem, radiation treatment planning software system - Produ... | The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour... | Class II | Elekta Inc |
| Apr 9, 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... | A software issue that may affect the analyzer's result accuracy. | Class II | The Binding Site Group, Ltd. |
| Apr 7, 2020 | Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 7, 2020 | FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00,... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N F... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 3, 2020 | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intend... | Observed an internal repetitive software glitch in ImmersiveView. | Class III | Immersivetouch Inc |
| Apr 3, 2020 | Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... | When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and... | Class II | Philips North America, LLC |
| Mar 31, 2020 | Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... | False positive reaction on the reagent. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 26, 2020 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... | In affected software version, of Positron emission tomography and computed tomography system, the... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 20, 2020 | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U30... | Automated External Defibrillators may not detect a patient connection due to mechanical wear-thr... | Class II | Physio-Control, Inc. |
| Mar 9, 2020 | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receive... | Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an ... | Class II | Sysmex America, Inc. |
| Mar 4, 2020 | RayStation standalone software treatment planning system, Model Numbers 4.0, ... | Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtu... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if non-applicable shock ... | Class II | Abbott |
| Feb 27, 2020 | Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software vers... | Editing an assay Test Definition and switching to another assay s Test Definition screen without ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2020 | Synaptive ImageDrive Clinical | A software defect negatively affects the quality of images taken during diagnostic imaging (mammo... | Class II | Synaptive Medical Inc |
| Feb 26, 2020 | ClearCanvas RIS/PACS | A software defect negatively affects the quality of images taken during diagnostic imaging (mammo... | Class II | Synaptive Medical Inc |
| Feb 24, 2020 | Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool... | Distributed without an approved 510(k) | Class II | Butterfly Network, Inc. |
| Feb 24, 2020 | Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volu... | Distributed without an approved 510(k) | Class II | Butterfly Network, Inc. |
| Feb 20, 2020 | RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment ... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment ... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor... | Class II | Philips North America, LLC |
| Feb 20, 2020 | RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone softw... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone soft... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 20, 2020 | RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone softw... | There is a potential for erroneous propagation of the current tabletop positions when applying pi... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 19, 2020 | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.... | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to ... | Class II | Haemonetics Corporation |
| Feb 18, 2020 | PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versi... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console S... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, ME... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Pa... | There is a software issue which may result in failure to monitor or control patient's bed exit me... | Class II | Hill-Rom Inc. |
| Feb 14, 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Ar... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... | Firm identified software issues which leads to the patient ID and patient information not being s... | Class II | ICU Medical, Inc. |
| Feb 12, 2020 | Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 12, 2020 | Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:Th... | Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... | Class II | Boston Scientific Corporation |
| Feb 11, 2020 | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - P... | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. | Class II | Intellijoint Surgical, Inc. |
| Feb 5, 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system con... | The top seal of some of the pouches was compromised which can allow moisture to enter that can im... | Class II | bioMerieux, Inc. |
| Feb 4, 2020 | CareFusion Alaris Syringe Module, Model 8110 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris Pump Module, Model 8100 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris PCA Module, Model 8120 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, 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.