The Recall Desk

FDA (Devices) recall action 85373

Gentell, Inc recalled 4 products on 2020-05-13

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-05-13
Critical
0
Units
116,792

Why these products were recalled

During an FDA audit, it was discovered that the product was not properly registered with FDA.

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.

1–4 of 4

  • LowFDA (Devices)··2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2020-05-13

    Gentell Honey Hydrogel Saturated Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 4,348 units of Gentell Honey Hydrogel Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 85,586 units of Gentell Honey Hydrogel 2"x2" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, f
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-05-13

    Gentell Honey Hydrogel Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling Gentell Honey Hydrogel because the product was not properly registered with the FDA, as discovered during an audit.

    Product
    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and seco
    Category
    Distribution
    0 states