Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING — Class II medical device recall Z-0400-2019
Terminated recall by Safe N Simple, LLC, reported 2018-11-14, distributed in CA. The sterilization process used was unqualified.
| Recall number | Z-0400-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safe N Simple, LLC, Clarkston, MI, United States |
| Recall initiated | 2018-08-22 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-03-17 |
| Distributed | CA |
| Quantity | 104 cases |
| Lot numbers | 18060563 |
| Model numbers | SNS58315 |
Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Reason for recall
The sterilization process used was unqualified.
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-0400-2019. 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.