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 |
|---|---|---|---|---|
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 w... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 760 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panor... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panv... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS Astound with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 780 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvi... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panor... | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 550 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 530 with software | Positron emission tomography and computed tomography x-ray systems have a software problem when S... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 7, 2026 | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 | Due to software issue with ultrasound system, doppler sample is displayed shallower than its actu... | Class II | Philips Ultrasound, LLC |
| Aug 7, 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 6, 2026 | Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1... | Software system may associate image data from one patient with another patient's record, potenti... | Class II | Volcano Corp |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 4, 2026 | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number... | When a bolus is included in a treatment plan and sent for secondary dose calculation, the softwar... | Class II | PTW FREIBURG |
| Aug 3, 2026 | Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANA... | Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the m... | Class II | Beckman Coulter Mishima K.K. |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected the accuracy of the... | Class II | Baxter Healthcare Corporation |
| Jul 31, 2026 | Enterprise Archive V8, software product for receiving, archiving, and sending... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Philips Patient Information Center iX REF:866389 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 31, 2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving,... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the stor... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Philips PIC iX Essentials REF:867093 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 30, 2026 | Et Control, Software option for anesthesia gas machine to achieve and maintai... | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... | Class II | Datex-Ohmeda, Inc. |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 24, 2026 | Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patie... | Due to a manufacturing issue (inadequate weld) for patient head positioning system. | Class II | QUANTUM OPS Inc |
| Jul 24, 2026 | Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penu... | Due to manufacturing issues reperfusion catheters may fracture. | Class II | Penumbra Inc. |
| Jul 23, 2026 | Velys Enabling Tech Robotic-Assist Station REF: 451611001 | Software issue within robotic controller which may cause unintended movement of the robotic arm d... | Class II | Medos International Sarl |
| Jul 22, 2026 | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 22, 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Merge Healthcare, Inc. |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Soft... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570... | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software ... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 17, 2026 | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Ex... | Due to blood-to-glycol leak in the heat exchanger. | Class II | SPECTRUM MEDICAL SRL |
| Jul 17, 2026 | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Ex... | Due to blood-to-glycol leak in the heat exchanger. | Class II | SPECTRUM MEDICAL SRL |
| Jul 16, 2026 | Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Appl... | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software i... | Class II | Tandem Diabetes Care, 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.