Smiths Medical CADD Medication Cassette Reservoir Recall: Incorrect Pressure Plate Risk
Smiths Medical recalls certain CADD medication cassette reservoirs with a potential incorrect pressure plate that could cause malfunction. Affected units include all lot numbers for 100mL reservoirs used with CADD pumps (excluding specific models).
Lower-risk recall
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
Contact the company
What happened, in plain English
Smiths Medical is recalling certain medication cassette reservoirs that may have an incorrect pressure plate. This could cause the reservoir to malfunction during use, potentially leading to medication delivery issues. Read more at govinfonow.com/recall/72949-smiths-medical-cadd-medication-cassette-reservoir-recall-incorrect-pressure-plate.
Source Summary by GovInfoNow · govinfonow.com/recall/72949-smiths-medical-cadd-medication-cassette-reservoir-recall-incorrect-pressure-plate · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0061-2018
Cite this page
“Smiths Medical CADD Medication Cassette Reservoir Recall: Incorrect Pressure Plate Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72949-smiths-medical-cadd-medication-cassette-reservoir-recall-incorrect-pressure-plate. Based on FDA recall #Z-0061-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0061-2018%22&limit=1).
Why it’s dangerous
The reservoirs may have an incorrect pressure plate that could cause the reservoir to malfunction during use. This might lead to improper medication delivery or other issues, but does not pose an immediate safety risk like injury or fire.
Who’s affected
Healthcare professionals using these reservoirs with CADD pumps (excluding CADD-Micro, CADD-MS 3, and CADD-TPN pumps) are most at risk. All units produced are affected.
How to tell if you have this one
Check for the product name 'CADD Medication Cassette Reservoir' with a 100mL capacity. All lot numbers are affected, and the product is used with CADD pumps (except CADD-Micro, CADD-MS 3, and CADD-TPN pumps).
- Brand
Smiths Medical- Category
Medical device
All 3 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
Terminated- Distribution
Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0060-2018 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).; All lot numbers | 2827352 units |
| Z-0061-2018 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).; All lot numbers | 11170535 units |
| Z-0062-2018 | CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).; All lot numbers | 1148189 units |
What to do — step by step
Check Product Details
Verify the product name and lot number to confirm if it's affected. All lot numbers are included in this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these reservoirs immediately?
No, the recall does not require immediate stoppage. The hazard is low risk and does not pose an immediate safety threat.
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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-0061-2018 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0061-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.