Safe N Simple No-Sting Skin Barrier Film — Class II medical device recall Z-2330-2018
Terminated recall by Safe N Simple, LLC, reported 2018-07-04, distributed in CA, FL, MI, NJ, NY, OH, PA, TX…. The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the pro
| Recall number | Z-2330-2018 |
|---|---|
| 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 | 2012-06-18 |
| Classified | 2018-06-28 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-05-28 |
| Distributed | CA, FL, MI, NJ, NY, OH, PA, TX, VA |
| Quantity | 17,592 |
| Reason classes | microbial contamination |
Product
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Reason for recall
The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.
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-2330-2018. 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.