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Lower risk Medical device recall · FDA · Published August 6, 2025

Smiths Medical CADD Reservoirs May Leak Medication - Recall

Smiths Medical recalls 50mL medication cassette reservoirs with weakened welds that could cause medication leakage. Affected units include specific lot numbers and product codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2522-2025Medical deviceSmiths Medical ›
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Recalling firmICU Medical Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer

Smiths Medical is recalling certain 50mL medication cassette reservoirs that may have weakened welds around the medication bag. This could lead to medication leakage, which might affect patient safety during medical treatments. Read more at govinfonow.com/recall/51665-smiths-medical-cadd-reservoirs-may-leak-medication-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51665-smiths-medical-cadd-reservoirs-may-leak-medication-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2522-2025

Cite this page

“Smiths Medical CADD Reservoirs May Leak Medication - Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51665-smiths-medical-cadd-reservoirs-may-leak-medication-recall. Based on FDA recall #Z-2522-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2025%22&limit=1).

The FDA announced on August 6, 2025, that ICU Medical Inc. is recalling Smiths Medical CADD Medication Cassette Reservoirs due to a risk of medication leakage from weakened bag welds. Owners should contact the company for a replacement.

How to tell if you have it

  • Brand: Smiths Medical
  • Product: CADD Medication Cassette Reservoir with clamp and female Luer, Nonvented stopper included, 50mL
  • Product Code: 21-7001-24
  • UDI/DI: 10610586022111
  • Lot Numbers: 6022008, 6022009, 6037749, 6062686, 6062687

The hazard

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 defect could result in medication leakage along the bag perimeter.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and a recall regarding pump decrement errors (June 10, 2026). Other recent recalls of similar products include Medline Medical Kits Recalled Due to Cracked Adhesive Risk (December 12, 2025), Medline Convenience Kits with Swan-Ganz Catheters Recalled Due to Leak Risk (May 28, 2026), and Medline IV Sets May Leak Chemicals and Break, Risking Patient Harm (December 31, 2025).

How to tell if you have this one

Check for product code 21-7001-24, lot numbers 6022008, 6022009, 6037749, 6062686, or 6062687. These reservoirs were sold with a nonvented stopper and female Luer connector.

  • Brand
    Smiths Medical
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2522-2025Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24; UDI/DI 10610586022111, Lot Numbers: 6022008, 6022009, 6037749, 6062686, 606268729811 units
Z-2523-2025Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24; UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691265500 units
Z-2524-2025Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24; UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695289098 units
Z-2525-2025Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24; UDI/DI 10610586027215, Lot Numbers: 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023, 6022024, 6022025, 6022026, 6022028, 6022030, 6022031, 6022032, 6026837, 6026839, 6037765, 6037768, 6037771, 6059294, 6059295, 6059296, 6062697, 6062698, 6077779, 6085509, 6092859, 6101810211750 units
Z-2526-2025Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24; UDI/DI 10610586027239, Lot Numbers: 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593, 6005601, 6012443, 6012470, 6012472, 6012474, 6012477, 6022033, 6022034, 6022039, 6022040, 6022041, 6022045, 6022046, 6022047, 6022048, 6022049, 6022051, 6022053, 6026851, 6026853, 6026854, 6026855, 6026856, 6026857, 6026858, 6026859, 6026861, 6026862, 6026863, 6026864, 6026865, 6026866, 6026867, 6026868, 6026869, 6026870, 6026872, 6026873, 6026874, 6026875, 6037772, 6037773, 6037774, 6037775, 6037776, 6037777, 6037778, 6037779, 6037780, 6037781, 6037782, 6053814, 6054005, 6054007, 6054008, 6054009, 6054010, 6054011, 6054013, 6054014, 6056238, 6062718, 6054012, 6062712, 6062710, 6062699, 6062714, 6062700, 6062701, 6062702, 6062705, 6062716, 6062703, 6062706, 6062721, 6062711, 6062723, 6062717987911 units
Z-2527-2025Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24; UDI/DI 10610586044007, Lot Numbers: 6037784, 605401515546 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify your reservoir's product code and lot numbers to confirm if it's affected.

How this recall unfolded

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Aug 6, 202512. FDA classified it Class II: Sep 4, 202523. Published in FDA’s Enforcement Report: Sep 10, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these reservoirs immediately?

The recall does not require immediate stoppage; affected units should be checked for the specific lot numbers and product code.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2522-2025 (August 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2522-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA