Gentell Hydrogel Ag Saturated Gauze — Class II drug recall D-0242-2017
Terminated recall by Gentell, Inc, reported 2017-01-11. CGMP Deviations
| Recall number | D-0242-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentell, Inc, Bristol, PA, United States |
| Recall initiated | 2016-12-15 |
| Classified | 2017-01-02 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2018-02-16 |
| Quantity | 3,000 gauzes |
| Reason classes | cgmp |
| NDC | 61551-0112-20, 61554-0114-24, 61554-0118-28 |
| Lot numbers | 11/18, 1121615, 1121713, 1122215, 1123315, 1125215, 1126515, 1127315, 1130015, 1133615 |
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
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0242-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.