smiths medical Medfusion Model 3500 Syringe pump — Class I medical device recall Z-0863-2024

Ongoing recall by Smiths Medical ASD Inc., reported 2024-02-07. Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery Durin

Recall number	`Z-0863-2024`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Smiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated	2023-12-19
Classified	2024-02-01
Reported by FDA	2024-02-07
Quantity	93,177 pumps
Reason classes	software
Model numbers	`3500`

Product

smiths medical Medfusion Model 3500 Syringe pump

Reason for recall

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0863-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.