The Recall Desk
ModerateFDA (Devices)·Z-1076-2026·Announced 2026-01-21

Preoperative kits recalled over recalled B. Braun administration sets inside

Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a supplier component recall over stuck check valves with no stated consequence or reported harm.

Plain-English summary

Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets are being recalled by Medline Industries, LP, covering pre-op kits under Medline SKUs DYKS1093B, DYKS1124C, DYKS1128C and DYKS1378B among the kits listed in the enforcement record.

The 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 record lists 11173 units, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.

The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.

The recalled product

Product
Allura Xper FD20/10; Model Number: 722029;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Procedure kit
Hazard
Affected units
4

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 (7)

  • Model Number: 722029
  • System Product Name: Allura Xper FD20/10
  • UDI-DI: 00884838054219
  • Serial Numbers: 30
  • 81
  • 80
  • 47

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · supplier recall

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