The Recall Desk
HighFDA (Devices)·Z-1055-2026·Announced 2026-01-21

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1055-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
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 (20)

  • Medline kit SKU ACC010271B
  • UDI/DI 10193489484953 (EA) 40193489484954 (CS)
  • Lot number 25IDB125
  • Lot number 25IDB400
  • Lot number 25JDB835
  • Lot number 25KDA036
  • Lot number 25KDA248
  • Medline kit SKU ACC010416B
  • UDI/DI 10195327223670 (EA) 40195327223671 (CS)
  • Lot number 25IDA545
  • Lot number 25JDB867
  • Medline kit SKU ACC010525C
  • UDI/DI 10198459027765 (EA) 40198459027766 (CS)
  • Lot number 25KDA768
  • Medline kit SKU ACC010688
  • UDI/DI 10195327432713 (EA) 40195327432714 (CS)
  • Lot number 25HDB656
  • Lot number 25IDA638
  • Lot number 25JDA666
  • Medline kit SKU ACC010770

Distribution

Distributed nationwide across the United States.

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