Medline procedure kits — Class II medical device recall Z-1708-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-05-07, distributed nationwide. It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking a
| Recall number | Z-1708-2025 |
|---|---|
| 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 | 2025-03-19 |
| Classified | 2025-05-01 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 240 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10889942529964, 40889942529965 |
| Lot numbers | 23KDB283 |
| Model numbers | DYKM1438 |
Product
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Reason for recall
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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-1708-2025. 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.