Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Feb 3, 2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... | The firm received reports of occurrences where the barcode reader misinterpreted the contents of... | Class II | Radiometer Medical ApS |
| Jan 28, 2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed... | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file r... | Class II | Qiagen Sciences LLC |
| Jan 24, 2020 | LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... | Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... | Class II | Abbott Gmbh & Co. KG |
| Jan 23, 2020 | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... | A software issue was identified which could result in user or patient injury, or may adversely im... | Class II | Ra Medical Systems, Inc. |
| Jan 22, 2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 22, 2020 | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... | Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jan 22, 2020 | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 22, 2020 | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36... | Past updates to programmers and transmitters may lead some implantable cardioverter defibrillator... | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Jan 17, 2020 | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... | A security-only update was released via remote diagnostics on January 14, 2020 to customers with ... | Class II | Beckman Coulter Inc. |
| Jan 13, 2020 | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... | if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... | Class II | Philips North America, LLC |
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen ... | Class II | Tosoh Bioscience Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 6, 2020 | ROSA One 3.1 Brain Application | Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... | Class II | MEDTECH SAS |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | ROSA Brain 3.0 Application-Brain | Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... | Class II | MEDTECH SAS |
| Dec 31, 2019 | Koios DS Breast <series 1.0>. The device is a software application which assi... | Affected software product versions were found during internal audit to have been marketed for sal... | Class II | Koios Medical, Inc. |
| Dec 23, 2019 | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN... | Class II | Philips North America, LLC |
| Dec 19, 2019 | CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... | Class II | Philips Medical Systems Gmbh, DMC |
| Dec 19, 2019 | RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4... | Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module ma... | Class II | RAYSEARCH LABORATORIES AB |
| Dec 19, 2019 | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... | Class II | Philips Medical Systems Gmbh, DMC |
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.