Manufacturer

Gentell, Inc

11 recalls in our database name Gentell, Inc as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2020-05-13

Of the 11 recalls from Gentell, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

ModerateFDA (Devices)·Z-1910-2020·2020-05-13
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
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1907-2020·2020-05-13
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
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1909-2020·2020-05-13
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
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1908-2020·2020-05-13
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1624-2020·2020-04-08
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1623-2020·2020-04-08
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
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1625-2020·2020-04-08
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
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1626-2020·2020-04-08
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0866-2017·2017-05-31
Gentell Recalls Moisture Barrier Cream Due to Manufacturing Deviations
Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream because it may not meet cGMP requirements.
Product
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0243-2017·2017-01-11
Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0242-2017·2017-01-11
Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
Category
Medical Device
Distribution
0 states