CLASS II Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report
Hydrogel Ag Saturated Gauze, 2"x2" recalled by Gentell
Gentell is recalling Gentell Hydrogel Ag Saturated Gauze, 2"x2"(. The recall was initiated on 15 Dec 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0242-2017
- FDA event ID
- 75982
- Recalling firm
- Gentell, Bristol, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2016
- FDA classified
- 2 Jan 2017
- Reported
- 11 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Dec 2016 | Recall initiated by company | |
| 2 Jan 2017 | Classified by FDA | +18 days |
| 11 Jan 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
United States
Questions about this recall
Is Hydrogel Ag Saturated Gauze, 2"x2"( recalled?
Yes. Gentell recalled Hydrogel Ag Saturated Gauze, 2"x2"( on 15 Dec 2016. The recall is Class II and its status is Terminated. Recall number D-0242-2017.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; Exp. 11/18
Where was it sold?
United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gentell
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound recalled | Gentell | Other | Nationwide |
| Device | CLASS II | Honey Hydrogel Hydrogel Tube recalled by Gentell | Gentell | Other | Nationwide |
| Device | CLASS II | Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound recalled | Gentell | Other | Nationwide |
| Device | CLASS II | Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound recalled | Gentell | Other | Nationwide |
| Device | CLASS II | Hydrogel Ag recalled by Gentell | Gentell | Other | Nationwide |