The Recall Desk

Manufacturer

American Surgical Company, LLC

1 recall in our database name American Surgical Company, LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2024-11-13

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

1–1 of 1

  • HighFDA (Devices)·Z-0287-2025·2024-11-13

    Surgical neurological sponges recalled for detaching X-ray markers

    American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.

    Product
    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
    Category
    Medical Device
    Distribution
    8 states