---
title: "Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion ... — FDA record Z-1542-2024 | Is It on Recall"
description: "Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740"
url: https://isitonrecall.com/recall/fda-device-z-1542-2024-smiths-medical-model-3010-syringe-pumps-a-protege-model-3010-b-medfusion-model-3010a-c-protege-uk-mo/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E — FDA record Z-1542-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
- **Reason**: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- **Classification**: Class II
- **Recalling firm**: Smiths Medical ASD Inc.
- **Quantity**: 27 pumps
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1542-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1542-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All serial numbers for pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a. 3010, UDI/DI none, Serial Numbers: M03315, M03910; b. 3010A, UDI/DI 10610586032097, Serial Numbers: M04601, M05551, M05782, M06829, M07259, M07334, M07339, M07342, M07345, M07371, M08269, M08750, M08815, M10253, M10267, M10871, M10876, M10965, M11872, M11896, M11899, M11901, M11905, M11915; c. 3010E, UDI/DI none, Serial Numbers: M05179 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 24, 2024
- **Recall initiation date**: Dec 19, 2023
- **Center classification date**: Apr 15, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1542-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical ASD Inc. records](https://isitonrecall.com/brand/smiths-medical-asd-inc/)