The Recall Desk

FDA (Devices) recall action 75665

DeRoyal Industries Inc recalled 2 products on 2016-12-14

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-12-14
Critical
0
Units
847

Why these products were recalled

DeRoyal received complaints of mold on Tennis Elbow Straps.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-12-14

    DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints

    DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.

    Product
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-14

    DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints

    DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.

    Product
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Distribution
    0 states