The Recall Desk

FDA (Devices) recall action 85034

Gentell, Inc recalled 4 products on 2020-04-08

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
2020-04-08
Critical
0
Units
85,987

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.

States named across these recalls

1–4 of 4

  • LowFDA (Devices)··2020-04-08

    Gentell Hydrogel Ag Wound Dressing Recalled for Registration Issues

    Gentell, Inc. is recalling Gentell Hydrogel Ag wound dressings because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, fir
    Category
    Distribution
    21 states
  • ModerateFDA (Devices)··2020-04-08

    Gentell Hydrogel Ag Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 53,134 units of Gentell Hydrogel Ag 2x2 gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second deg
    Category
    Distribution
    21 states
  • LowFDA (Devices)··2020-04-08

    Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Distribution
    21 states
  • ModerateFDA (Devices)··2020-04-08

    Gentell Hydrogel Ag Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4 gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Distribution
    21 states