SWIN 2017 database — Class II medical device recall Z-1939-2020
Terminated recall by Remel Inc., reported 2020-05-20. Potential for out of range microbial results
| Recall number | Z-1939-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc., Oakwood Village, OH, United States |
| Recall initiated | 2019-01-04 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2020-08-17 |
| Quantity | 250 |
| Reason classes | microbial contamination |
| Model numbers | YSW4000 |
Product
SWIN 2017 database, Model YSW4000
Reason for recall
Potential for out of range microbial results
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-1939-2020. 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.