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 87 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
FDA Z-1553-2026
Medical Device High
Mar 18, 2026 Recall: Jan 30, 2026
Details
GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA Z-1524-2026
Medical Device High
Mar 18, 2026 Recall: Jan 20, 2026
Details
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
FDA Z-1428-2026
Medical Device High
Feb 25, 2026 Recall: Nov 17, 2025
Details
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Z-1360-2026
Medical Device High
Feb 18, 2026 Recall: Jan 20, 2023
Details
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Z-1356-2026
Medical Device High
Feb 18, 2026 Recall: Jan 20, 2023
Details
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Z-1357-2026
Medical Device High
Feb 18, 2026 Recall: Jan 20, 2023
Details
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Z-1358-2026
Medical Device High
Feb 18, 2026 Recall: Jan 20, 2023
Details
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Z-1359-2026
Medical Device High
Feb 18, 2026 Recall: Jan 20, 2023
Details
FDA Z-1238-2026
Medical Device High
Feb 11, 2026 Recall: Nov 2, 2025
Details
FDA Z-1217-2026
Medical Device High
Feb 4, 2026 Recall: Nov 6, 2025
Details
FDA Z-1147-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1145-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1141-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1148-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1150-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1144-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1152-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1143-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1154-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1146-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1149-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1153-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1151-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1142-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
FDA Z-1140-2026
Medical Device High
Jan 28, 2026 Recall: Oct 24, 2025
Details
Showing 51 - 75 of 87 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.