Smiths Medical Medfusion Pump Software V1.1 Recall: Risk of Incorrect Syringe Detection
Smiths Medical recalls Medfusion syringe infusion pumps with software version V1.1 due to potential syringe size detection errors. Affected units may trigger "Invalid Syringe Size" alarms during fluid administration. Contact for remedy details.
Use caution until it’s fixed
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Contact the company
What happened, in plain English
Smiths Medical is recalling syringe infusion pumps with software version V1.1 because the syringe barrel clamp mechanism might loosen, causing the pump to incorrectly detect syringe size and trigger an alarm. This could lead to improper fluid administration during critical treatments like blood or medication delivery. Read more at govinfonow.com/recall/73127-smiths-medical-medfusion-pump-software-v1-1-recall-risk-of.
Source Summary by GovInfoNow · govinfonow.com/recall/73127-smiths-medical-medfusion-pump-software-v1-1-recall-risk-of · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0313-2018
Cite this page
“Smiths Medical Medfusion Pump Software V1.1 Recall: Risk of Incorrect Syringe Detection.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73127-smiths-medical-medfusion-pump-software-v1-1-recall-risk-of. Based on FDA recall #Z-0313-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0313-2018%22&limit=1).
Why it’s dangerous
The syringe barrel clamp mechanism may loosen, reducing the pump's ability to accurately measure syringe diameter. This can cause the pump to trigger an "Invalid Syringe Size" alarm, potentially leading to incorrect fluid administration during critical treatments.
Who’s affected
Healthcare professionals using Medfusion pumps with software version V1.1 for administering fluids like blood, medications, or other therapeutic solutions are most at risk. Patients receiving such treatments could experience inaccurate dosing if the pump malfunctions.
How to tell if you have this one
Check for the product name 'Medfusion Syringe Infusion Pump' with software version V1.1. The model number is 4000, and these pumps were sold with reference number 4000-0101-51.
- Brand
Smiths Medical- Category
Medical device
All 2 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) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
| Recall number | Product, codes & lots |
|---|---|
| Z-0313-2018 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.; Model No. 4000; Reference No. 4000-0101-51 |
| Z-0314-2018 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.; Model No. 3500; Reference No. 3500-0600-51 |
What to do — step by step
Check Pump Software Version
Verify the software version on your Medfusion pump; affected units have version V1.1.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.” 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 7.6 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.
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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-0313-2018 (August 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0313-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.