FDA Device recall Z-1624-2020
Gentell Hydrogel Ag 4x4, model no
- FDA Device
- Class II
- ongoing
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of Gentell Hydrogel Ag 4x4, model no by Gentell, citing during an FDA audit, it was discovered that the product was not properly registered with FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1624-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-02-27 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gentell |
| Distribution | US |
Product
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze 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
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Identifiers
| code_info | 1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1624-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.