SUNSTAR Butler Clear Dip — Class II medical device recall Z-1382-2021
Terminated recall by Sunstar Americas, Inc., reported 2021-04-21. Product may be contaminated with Burkholderia contaminans.
| Recall number | Z-1382-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2021-03-23 |
| Classified | 2021-04-09 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2023-08-28 |
| Countries outside the US | HK, JP, MX, MY, TH, TW |
| Quantity | 19,471 bottles |
| Pathogens | burkholderia |
| Lot numbers | 532952, 535180, 536513, 536514, 539487, 551038, 551039 |
Product
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Reason for recall
Product may be contaminated with Burkholderia contaminans.
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-1382-2021. 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.