The Recall Desk
Severity pendingFDA (Devices)·Z-1058-2026·Announced 2026-01-21

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:

Pending LLM rewrite. Source: FDA_DEVICE Z-1058-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Medline kit SKU DYKS1339B
  • UDI/DI 10195327386726(EA) 40195327386727 (CS)
  • Lot Number 25HMC849
  • Medline kit SKU DYKS1339C
  • UDI/DI 10198459523434(EA) 40198459523435 (CS)
  • Lot Number 25IMG807
  • Lot Number 25JMF937
  • Medline kit SKU DYKS1359B
  • UDI/DI 10195327566449(EA) 40195327566440 (CS)
  • Lot Number 25JMD518
  • Medline kit SKU DYKS1534D
  • UDI/DI 10198459310911(EA) 40198459310912 (CS)
  • Lot Number 25HMD322
  • Lot Number 25JMG543.

Distribution

Distributed nationwide across the United States.

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