🔍 RecallPedia

Gentell

11 recalls •
🏥 Medical Devices 💊 Drugs
• Categories: Surgical Instruments, Other Medical Devices, Other Drugs

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, first and second-degree burns, post-surgical incisions, cuts and abrasions.

🏥 Medical Devices Class I - Dangerous

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

Mar 26, 2020 Surgical Instruments Nationwide View Details →

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, first and second-degree burns, post-surgical incisions, cuts and abrasions.

🏥 Medical Devices Class I - Dangerous

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

Mar 26, 2020 Surgical Instruments Nationwide View Details →

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 second-degree burns, post-surgical incisions, cuts and abrasions.

🏥 Medical Devices Class I - Dangerous

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

Mar 26, 2020 Surgical Instruments Nationwide View Details →

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, first and second-degree burns, post-surgical incisions, cuts and abrasions

🏥 Medical Devices Class I - Dangerous

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

Mar 26, 2020 Surgical Instruments Nationwide View Details →

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 degree burns and skin tears. It provides a moist wound environment for healing.

🏥 Medical Devices Class I - Dangerous

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

Feb 27, 2020 Other Medical Devices Nationwide View Details →

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, first and second degree burns and skin tears. It provides a moist wound environment for healing.

🏥 Medical Devices Class I - Dangerous

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

Feb 27, 2020 Other Medical Devices Nationwide View Details →

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 degree burns and skin tears. It provides a moist wound environment for healing.

🏥 Medical Devices Class I - Dangerous

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

Feb 27, 2020 Other Medical Devices Nationwide View Details →

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 degree burns and skin tears. It provides a moist wound environment for healing.

🏥 Medical Devices Class I - Dangerous

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

Feb 27, 2020 Other Medical Devices Nationwide View Details →