CADD yellow 100 mL reservoirs recalled over weakened medication bag welds
Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.
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: 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 Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer, including a non-vented stopper, 100 mL, product code 21-7300-24, UDI/DI 10610586027192, is being recalled. Affected lot numbers include 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835 and 6026836, with the full list in the recall notice. The recall covers 289,098 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" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
- Manufacturer
- ICU Medical Inc.
- Affected units
- 289,098
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 10610586027192
- Lot Numbers: 6012453
- 6022016
- 6022019
- 6026832
- 6026833
- 6026834
- 6026835
- 6026836
- 6037755
- 6037756
- 6037757
- 6037758
- 6037759
- 6037760
- 6053986
- 6053987
- 6053988
- 6053990
- 6053989
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 →Related recalls
Same manufacturer · ICU Medical Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · weld failure
See all →- SevereElectric fat tire trikes recalled after frames broke near a weld
CPSC · 2025-12-18
- HighPurple cap administration sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- High20mm vented vial spikes recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighDouble port syringe transfer sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05