The Recall Desk

Manufacturer

SteriGear, LLC

1 recall in our database name SteriGear, LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2014-07-02

Of the 1 recalls from SteriGear, 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-1848-2014·2014-07-02

    SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction

    SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.

    Product
    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the U
    Category
    Medical Device
    Distribution
    Distributed nationwide