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

Recall Z-0035-2026 — BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Chec

U.S. FDA — Device Enforcement · United States · 2025-09-11 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0035-2026
Date of alert: 2025-09-11
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: CareFusion 303, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10885403235528

Reported risk: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

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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