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 476 - 500 of 1,678 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
FDA Z-2213-2026
Medical Device High
May 27, 2026 Recall: Apr 23, 2026
Details
FDA Z-2225-2026
Medical Device High
May 27, 2026 Recall: Apr 28, 2026
Details
FDA Z-2221-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
FDA Z-2217-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
Swan-Ganz Pacing Catheter, Models: D200F7;
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
FDA Z-2204-2026
Medical Device High
May 27, 2026 Recall: Apr 8, 2026
Details
FDA Z-2214-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
FDA Z-2216-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
FDA Z-2219-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
FDA Z-2218-2026
Medical Device High
May 27, 2026 Recall: Apr 21, 2026
Details
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
FDA Z-2227-2026
Medical Device High
May 27, 2026 Recall: Apr 28, 2026
Details
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
FDA Z-2203-2026
Medical Device High
May 27, 2026 Recall: Apr 8, 2026
Details
FDA Z-2182-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
FDA Z-2147-2026
Medical Device High
May 20, 2026 Recall: Mar 24, 2026
Details
FDA Z-2175-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
FDA Z-2178-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA Z-2142-2026
Medical Device High
May 20, 2026 Recall: Mar 24, 2026
Details
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA Z-2140-2026
Medical Device High
May 20, 2026 Recall: Mar 24, 2026
Details
FDA Z-2193-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
FDA Z-2150-2026
Medical Device High
May 20, 2026 Recall: Mar 26, 2026
Details
FDA Z-2197-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
FDA Z-2196-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
FDA Z-2184-2026
Medical Device High
May 20, 2026 Recall: Apr 10, 2026
Details
FDA Z-2137-2026
Medical Device High
May 20, 2026 Recall: Mar 19, 2026
Details
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA Z-2138-2026
Medical Device High
May 20, 2026 Recall: Mar 24, 2026
Details
FDA Z-2161-2026
Medical Device High
May 20, 2026 Recall: Apr 13, 2026
Details
Showing 476 - 500 of 1,678 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.