Medline procedure kits — Class II medical device recall Z-1709-2025
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-1709-2025 |
|---|---|
| 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 | 822 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10080196151561, 10193489849035, 10195327034108, 10195327417734, 10195327493165, 10889942903863, 40080196151562, 40193489849036, 40195327034109, 40195327417735, 40195327493166, 40889942903864 |
| Lot numbers | 23KBB406, 23KBW508, 23KBX338, 23KBX632, 23KDA001, 23LDA218, 23LDA281, 23LDA746, 23LDA814 |
| Model numbers | DYNDA1359A, DYNDA1360B, DYNDC1311C, DYNDC3185, EDUC05015A, EDUC1024A |
Product
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.
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-1709-2025. 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.