Medline procedure kits labeled as: 1) Port Access Kit — Class II medical device recall Z-1040-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-02-05, distributed nationwide. Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TO
| Recall number | Z-1040-2025 |
|---|---|
| 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 | 2024-11-18 |
| Classified | 2025-01-28 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 749 units |
| UPC / GTIN / UDI-DI | 00653160372342, 00653160376968, 10653160372349, 10653160376965 |
| Lot numbers | 2024040490, 2024050990, 2024073190, 2024082790, 2024101790 |
Product
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Reason for recall
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
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-1040-2025. 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.