The Recall Desk

FDA (Devices) recall action 71256

United Surgical Associates recalled 3 products on 2015-06-03

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-06-03
Critical
0
Units
3,294

Why these products were recalled

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2015-06-03

    United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label

    United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-06-03

    United Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label

    United Surgical Associates is recalling 1,278 Elastic Ankle Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-06-03

    United Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label

    United Surgical Associates is recalling 756 Keo elastic wrist braces because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Distribution
    1 state