Hydrogel Ag Saturated Gauze (Gentell) – CGMP Deviation (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Gentell, Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Gentell, Inc is recalling Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 6 due to CGMP Deviations. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026