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

Recall Z-2522-2025 — Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

U.S. FDA — Device Enforcement · United States · 2025-08-06 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2522-2025
Date of alert
2025-08-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10610586022111
Reported risk: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
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.