The Recall Desk

Manufacturer

American Catheter Corp

1 recall in our database name American Catheter Corp as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-07-29

Of the 1 recalls from American Catheter Corp 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-2191-2015·2015-07-29

    American Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure

    American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.

    Product
    American Catheter / Cholangiogram Catheter 9100 Series.
    Category
    Medical Device
    Distribution
    21 states