Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion… — Class II medical device recall Z-0653-2022
Ongoing recall by Smiths Medical ASD Inc., reported 2022-02-23, distributed nationwide. There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error cod
| Recall number | Z-0653-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2015-12-03 |
| Classified | 2022-02-17 |
| Reported by FDA | 2022-02-23 |
| Distributed | Nationwide (US) |
| Model numbers | 3500, 4000, 40000, G6000361, G6000435, G6001260, G6001560, G6001562, G6002728 |
Product
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
Reason for recall
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
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-0653-2022. 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.