Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 22, 2019 | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 ... | There is a potential that one or more image series (i.e., all images within an image set) may b... | Class II | GE Healthcare, LLC |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human ... | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results wh... | Class II | DRG Instruments GmbH |
| May 21, 2019 | LVivo EF app on Vscan Extend. Sold under the following product names: a... | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo E... | Class II | GE Healthcare, LLC |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| May 21, 2019 | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack... | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | Class II | Dutch Ophthalmic USA, Inc. |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 20, 2019 | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... | Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... | Class II | Medtronic Inc. |
| May 20, 2019 | The Visibly Online Refractive Vision Test which is part of the Visibly Vision... | Lack of 510K clearance | Class II | Opternative Inc |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 17, 2019 | Beckman Coulter Power Express Sample Processing System AU5800XL connection un... | Potential exposure to biohazard. Software design problem causes excess speed and vibrations in... | Class II | Beckman Coulter Inc. |
| May 17, 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... | Class II | Arrow International Inc |
| May 17, 2019 | EGIA45 CT AR MD THK REL, EGIA45CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255... | There is a potential that one or more images or image series may be missing from exams without a ... | Class II | GE Healthcare, LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-00... | There is a potential that one or more images or image series may be missing from exams without a ... | Class II | GE Healthcare, LLC |
| May 17, 2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 16, 2019 | Centricity PACS Foundation Centricity PACS software product is intended fo... | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... | Class II | GE Healthcare, LLC |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| May 16, 2019 | GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory ... | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | Class II | GE Healthcare, LLC |
| May 16, 2019 | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital... | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | Class II | GE Healthcare, LLC |
| May 16, 2019 | Centricity Universal Viewer 6.0 Is a device that displays medical images a... | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... | Class II | GE Healthcare, LLC |
| May 16, 2019 | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Incorrect coil length on the label | Class II | Codman & Shurtleff Inc |
| May 15, 2019 | InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) ... | There is a potential for an unexpected increase in stimulation during InterStim programming with ... | Class II | Medtronic Neuromodulation |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 14, 2019 | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.... | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during c... | Class I | Edwards Lifesciences, LLC |
| May 13, 2019 | BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inh... | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Nu... | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer SST Part/Catalog No.365967 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer SST- Amber Part/Catalog Number: 365978 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 10, 2019 | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
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.