Gentell Hydrogel Ag 4oz — Class II medical device recall Z-1626-2020
Ongoing recall by Gentell, Inc, reported 2020-04-08, distributed nationwide. During an FDA audit, it was discovered that the product was not properly registered with FDA.
| Recall number | Z-1626-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentell, Inc, Bristol, PA, United States |
| Recall initiated | 2020-02-27 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, CR, ES, MX, PA, RO, ZA |
| Quantity | 6,395 |
Product
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
Reason for recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
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/Z-1626-2020. 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.