Medline convenience kits containing BD Insyte Autoguard Shielded IV… — Class II medical device recall Z-2043-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-07-09, distributed nationwide. Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded
| Recall number | Z-2043-2025 |
|---|---|
| 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 | 2025-05-23 |
| Classified | 2025-06-30 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 186 units |
| UPC / GTIN / UDI-DI | 10193489472493, 10193489651683, 10195327226589, 10198459192074, 10884389559529, 10889942831746, 40193489472494, 40193489651684, 40195327226580, 40198459192075, 40884389559520, 40889942831747 |
| Lot numbers | 24LDA106, 24LDA260, 24LDA268, 24LDA269, 24LDA823, 24LDB092 |
| Model numbers | ACC010254B, ACC010256, ACC010316A, ACC010389C, ACC010627, ACC010898 |
Product
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
Reason for recall
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
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-2043-2025. 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.