Lower riskMedical device recall · FDA · Published October 10, 2022
Smiths Medical Medfusion 4000 Infusion Pump Software V1.6.0/V1.6.1 May Cause Delay
Smiths Medical recalls Medfusion Model 4000 Syringe Infusion Pumps with software versions V1.6.0 or V1.6.1 that may delay sending infusion start messages to electronic health records, potentially affecting patient documentation and treatment programming.
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer
Smiths Medical is recalling Medfusion Model 4000 Syringe Infusion Pumps with specific software versions (V1.6.0 or V1.6.1) that may delay sending infusion start messages to electronic health record systems. This could affect how treatments are programmed and documented for patients receiving fluids like blood, drugs, or antibiotics. Read more at govinfonow.com/recall/59929-smiths-medical-medfusion-4000-infusion-pump-software-v1-6-0.
“Smiths Medical Medfusion 4000 Infusion Pump Software V1.6.0/V1.6.1 May Cause Delay.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59929-smiths-medical-medfusion-4000-infusion-pump-software-v1-6-0. Based on FDA recall #Z-0272-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0272-2023%22&limit=1).
The FDA announced on Oct. 10, 2022, that Smiths Medical ASD Inc. is recalling Medfusion Model 4000 Syringe Infusion Pumps with software versions V1.6.0 or V1.6.1 due to a potential delay in sending infusion start messages to third-party electronic health record systems. The agency said the issue may affect infusion auto-programming and documentation.
How to tell if you have it
Brand: Smiths Medical
Product: Medfusion Model 4000 Syringe Infusion Pump
Distribution: US states of Indiana, Texas and Virginia
The hazard
The recall addresses a potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems. According to the FDA, this delay may affect infusion auto-programming on the pump and documentation.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Smiths Medical CADD-Solis Infusion Pumps (April 10, 2025), Smiths Medical CADD-Solis VIP Infusion Pump Recall (April 10, 2025), and Smiths Medical CADD Solis HSPCA Pump (April 10, 2025). Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026), Medtronic SynchroMed Flex Infusion Software Issue (April 8, 2026), and ICU Medical LifeShield Drug Library Management v2.2.1 recall (Nov. 24, 2025).
How to tell if you have this one
Check for the Medfusion Model 4000 Syringe Infusion Pump with software versions V1.6.0 or V1.6.1. The product has specific serial numbers and UDI codes listed in the recall notice. These pumps are used for precise fluid administration in clinical settings.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version on the pump's display or in the device settings to confirm if it is V1.6.0 or V1.6.1.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “US distribution to states of: Indiana, Texas and Virginia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Texas, Virginia.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0272-2023 (October 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0272-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 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.