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Gentell

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Calcium Alginate Ag (Silver) Dressing (4x4 in)	GEN-13420	FDA UDI	U	Active
Super Absorbent Dressing (8 x 8 in)	GEN-19380	FDA UDI	Class I	Active
Gentell Hydrogel Sheet Dressing	GEN-11700	FDA UDI	Class I	Active
Gentell Hydrogel Spray Gel, Appligard Squeeze	K990440	FDA 510(k)	U	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 26, 2020	Z-1910-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Mar 26, 2020	Z-1908-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Mar 26, 2020	Z-1907-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Mar 26, 2020	Z-1909-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Feb 27, 2020	Z-1624-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Feb 27, 2020	Z-1625-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Feb 27, 2020	Z-1626-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.
Feb 27, 2020	Z-1623-2020	—	open, classified	During an FDA audit, it was discovered that the product was not properly registered with FDA.