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Gentell, Inc

FDA Regulatory Profile

Gentell, Inc has 11 FDA recalls, 5 inspections, 1 510(k) clearance and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Gentell, Inc" and its spelling variant "Gentell".

Latest recall: Z-1909-2020 · Class II · Mar 26, 2020
Latest inspection: Sep 16, 2026 · NAI
Latest 510(k): Aug 12, 1999

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	11	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Gentell, Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	Recall records
2026	1	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	0	8
2019	2	0
2018	0	0
2017	0	1

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

11 recall records from Dec 15, 2016 to Mar 26, 2020.

Number	Class	Product	Date
Z-1909-2020	Class II	Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and…	Mar 26, 2020
Z-1908-2020	Class II	Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and…	Mar 26, 2020
Z-1910-2020	Class II	Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100%…	Mar 26, 2020
Z-1907-2020	Class II	Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and…	Mar 26, 2020
Z-1623-2020	Class II	Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare…	Feb 27, 2020
Z-1624-2020	Class II	Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare…	Feb 27, 2020
Z-1626-2020	Class II	Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare…	Feb 27, 2020
Z-1625-2020	Class II	Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare…	Feb 27, 2020
D-0866-2017	Class II	Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal…	Apr 19, 2017
D-0243-2017	Class II	Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA…	Dec 15, 2016
D-0242-2017	Class II	Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC…	Dec 15, 2016

Recent FDA inspections

5 inspections from Aug 25, 2015 to Sep 16, 2026.

Date	Site	Product	Classification	FEI
Sep 16, 2026	Bristol, PA	Devices	No Action Indicated (NAI)	1000522686
Dec 16, 2019	Bristol, PA	Devices	Voluntary Action Indicated (VAI)	3013160720
Dec 12, 2019	Bristol, PA	Drugs	Voluntary Action Indicated (VAI)	1000522686
Dec 13, 2016	Bristol, PA	Food/Cosmetics	No Action Indicated (NAI)	1000522686
Aug 25, 2015	Bristol, PA	Devices	Official Action Indicated (OAI)	1000522686

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Gentell, Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 5, 2015.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000522686	Bristol, PA	4	Sep 16, 2026
FEI 3013160720	Bristol, PA	1	Dec 16, 2019

Recent 510(k) clearances

1 510(k) clearance on Aug 12, 1999.

K-Number	Device	Date
K990440	GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE	Aug 12, 1999

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