Agency classClass IIOur severity:High FDA (Devices)·Z-2526-2025·Announced 2025-09-10

CADD 100 mL flow stop reservoirs recalled over weakened bag welds

Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; leakage from a medication reservoir could interrupt or reduce a dose, and no injuries are reported.

Plain-English summary

The Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer, including a non-vented stopper, 100 mL, product code 21-7302-24, UDI/DI 10610586027239, is being recalled. Affected lot numbers include 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593 and 6005601, with the full list in the recall notice. The recall covers 987,911 units distributed worldwide.

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing, which could result in medication leakage along the bag perimeter. The FDA classified the action as Class II.

Hospitals, infusion providers and home care patients should check lot numbers against the recall notice and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Manufacturer: ICU Medical Inc.
Category: Medical Device — Infusion Supplies
Hazard: weld-failure
medication-leakage
infusion-supplies
class-ii
Affected units: 987,911

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)

UDI/DI 10610586027239
Lot Numbers: 4468669
4468670
4468671
4468677
6004936
6005591
6005593
6005601
6012443
6012470
6012472
6012474
6012477
6022033
6022034
6022039
6022040
6022041
6022045

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by ICU Medical Inc. 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 6 products in this recall →

Same manufacturer · ICU Medical Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · weld failure