The Recall Desk

Manufacturer

Braemar Manufacturing, LLC

3 recalls in our database name Braemar Manufacturing, LLC as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2025-01-01

Of the 3 recalls from Braemar Manufacturing, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • SevereFDA (Devices)·Z-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1459-2020·2020-03-18

    Braemar DL900 Holter Monitor Recalled for Operational Failure

    Braemar Manufacturing is recalling DL900 Holter Monitors because a software issue prevents new patient studies from starting. Existing recordings can still be downloaded.

    Product
    Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1460-2020·2020-03-18

    Braemar DL950 Holter Monitor Recall Due to Startup Error

    Braemar Manufacturing is recalling DL950 Holter Monitors because a software issue prevents new patient studies from starting.

    Product
    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide