Medfusion Syringe Pump — Class II medical device recall Z-0076-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2023-10-18, distributed nationwide. A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection
| Recall number | Z-0076-2024 |
|---|---|
| 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 | 2023-08-16 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 20,815 pumps |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10610586032318 |
| Model numbers | 3500-500 |
Product
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Reason for recall
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
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-0076-2024. 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.