Gentell Recalls
11 recalls on record · January 11, 2017 to May 13, 2020 · Drugs, Medical Devices
Recalls by year
17
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 13, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Mode
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
May 13, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermu
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
May 13, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermu
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
May 13, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermu
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
April 8, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
April 8, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydro
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
April 8, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydro
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
April 8, 2020Medical DevicesFDA
Gentell, Inc recalls Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrog
Hazard: During an FDA audit, it was discovered that the product was not properly registered with FDA.
May 31, 2017DrugsFDA
Gentell, Inc recalls Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristo
Hazard: GMP Deviations; product may not meet cGMP requirements
January 11, 2017DrugsFDA
Gentell, Inc recalls Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Hazard: CGMP Deviations
January 11, 2017DrugsFDA
Gentell, Inc recalls Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufa
Hazard: CGMP Deviations