Lab Kit — Class II medical device recall Z-0355-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-11-20, distributed nationwide. Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-ter
| Recall number | Z-0355-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-23 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 626,305 total |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10195327088392, 40195327088393 |
| Lot numbers | 24IMC246 |
Product
Lab Kit, SKU DYLAB1018; Component No. 503581
Reason for recall
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
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-0355-2025. 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.