The Recall Desk

Manufacturer

Elite Biomedical Solutions LLC

2 recalls in our database name Elite Biomedical Solutions LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
1
Severe
1
Most recent
2015-08-26

Of the 2 recalls from Elite Biomedical Solutions LLC we have scored against our rubric, 1 (50%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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.

1–2 of 2

  • CriticalFDA (Devices)·Z-2372-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

    Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

    Product
    Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2371-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Frame Membranes

    Elite Biomedical Solutions LLC is recalling 609 Alaris Medley LVP Frame Membranes because the defect could allow fluid intrusion, potentially leading to injury or death.

    Product
    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide