FDA device recall and safety alerts

Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Search FDA medical device recalls and early alerts for equipment, software, implants, monitors, diagnostic tools and patient-use devices. Match device name, company, recall class, product code, UDI, model, lot and serial details.

Search Medical Device Recalls By Device, Company Or Recall Class

Use this medical device recall search to check FDA device notices by device name, company, product code, lot number, recall class, risk level or correction/removal details.

Medical Device Recall Alerts List

Showing 51 - 75 of 433 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.
FDA Z-3332-2026
Medical Device High
Oct 7, 2026 Recall: Aug 3, 2026
Details
FDA Z-0046-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0055-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0063-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0019-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0013-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0014-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0056-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
FDA Z-3311-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
FDA Z-0005-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Computed Tomography X-ray System, Model: uCT 760 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Z-3279-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Z-3285-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
FDA Z-0059-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0065-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Z-3286-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
FDA Z-0044-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0039-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0021-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
FDA Z-3310-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
FDA Z-0006-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0025-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0007-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
FDA Z-3307-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
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 Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Z-3282-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
FDA Z-0015-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Showing 51 - 75 of 433 product recalls

Medical Device Recalls Today

Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.

Search The Device Label

Use the device name, company, product code, UDI, model, catalog number, serial number, lot number, software version or implant card details.

Recall Class And Risk Level

Class I recalls are generally the most serious. Read the FDA notice for patient risk, affected devices, correction/removal steps and clinical action.

What To Check On A Device Label

If the device supports or monitors health, do not stop treatment based only on a search result. Confirm with the official notice and your clinician when needed.

How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Match The Exact Medical device

Use each recall result to compare device name, company, product code, model, serial, lot number, UDI and software version. A similar name is not enough; recalls often apply only to specific versions or production ranges.

Read The Recall Hazard

Check the notice for FDA recall class, patient risk, correction, removal and clinical action. This helps you decide whether the item should be stopped immediately or handled through a normal remedy process.

Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.

Medical Device Recalls: FDA Device Safety Alerts And Recall Notices FAQ

Short answers for checking whether a specific item is included in this recall category.

How do I know if this medical device is recalled?

Search the product name or brand, then compare model, serial, lot, code, date, retailer and official recall number details on the detail page.

What should I do after finding a matching recall?

Stop using the product if the official notice says to do so, keep the label or packaging, and follow the remedy instructions for repair, refund, replacement or disposal.

Why can two similar products have different recall status?

Recalls can be limited to certain production dates, factories, lots, model numbers, colors, sizes, retailers or distribution areas.

Is this page the official recall notice?

No. This page helps you search public recall data. Use the linked agency or company notice as the final source before taking action.