BUTLER Clear Dip — Class II medical device recall Z-0720-2022
Terminated recall by Sunstar Americas, Inc., reported 2022-03-09, distributed nationwide. Product lacks premarket clearance.
| Recall number | Z-0720-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2022-01-14 |
| Classified | 2022-03-03 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 22,514 units |
Product
BUTLER Clear Dip, 12 bottles/case
Reason for recall
Product lacks premarket clearance.
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-0720-2022. 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.