Braemar Manufacturing, LLC: Medical Device Recall in 2025 - (Recall #: Z-0708-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

Product Classification:

Class I

Date Initiated: December 18, 2024

Date Posted: January 1, 2025

Recall Number: Z-0708-2025

Event ID: 95837

Reason for Recall:

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

Status: Ongoing

Product Quantity: ~130,000 with 41,282 customers (1 software copy used)

Code Information:

Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

Distribution Pattern:

US Nationwide distribution including PR.

Voluntary or Mandated:

Voluntary: Firm initiated