Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1057-2026 — Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline k

U.S. FDA — Device Enforcement · United States · 2025-11-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1057-2026
Date of alert: 2025-11-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medline Industries, LP
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10195327521660

Reported risk: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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