FDA Device recall Z-0401-2019
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345 by Safe N Simple, citing the sterilization process used was unqualified.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0401-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-22 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Safe N Simple |
| Distribution | CA |
Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Reason
The sterilization process used was unqualified.
Identifiers
| code_info | lot number 18060564 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2019%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.