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 76 - 100 of 433 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; 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-3315-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; 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-3312-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
FDA Z-0053-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0016-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0049-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
FDA Z-3275-2026
Medical Device High
Oct 7, 2026 Recall: Aug 20, 2026
Details
FDA Z-0057-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0017-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0050-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0062-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0026-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0043-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0036-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0052-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0027-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0051-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Upgrade dStream; Model number (REF): 782127; 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-3316-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
Computed Tomography X-ray System, Model: uCT ATLAS 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-3281-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
Computed Tomography X-ray System, Model: uCT 780 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-3280-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S 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-3287-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
FDA Z-0033-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
FDA Z-3155-2026
Medical Device High
Oct 7, 2026 Recall: Aug 18, 2026
Details
FDA Z-0040-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0020-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0009-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Showing 76 - 100 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.