Smiths Medical syringe pumps recalled for molding defect in barrel clamp guide
Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a molding defect could potentially cause incorrect syringe size identification leading to medication dosing errors. Per the rubric, this is a risk-of-harm medical device where injury has not yet been reported, warranting a High (3) severity rating.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Model 3010 syringe pumps, including Protege Model 3010, Medfusion Model 3010A, and Protege UK Model 3010E variants. These pumps were manufactured or serviced with a Barrel Clamp Guide component (Part Number G6000716, affected lot numbers P0407365, P0486670, and P0561740) between July 2016 and April 2021.
The molding defect in the barrel clamp guide may cause the spring within the barrel clamp assembly to slip. If this occurs, the pump may fail to recognize a loaded syringe or may incorrectly identify the syringe size. Incorrect syringe size identification could result in the pump delivering an incorrect medication dose.
Specific serial numbers for affected pumps of each model variant have been identified. The recall affects 27 pumps distributed worldwide. Customers who own affected pumps should immediately verify their device serial number against the recall list and contact Smiths Medical ASD Inc. for instructions on repair or replacement.
The recalled product
- Product
- Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion pump
- Hazard
- molding-defect
- spring-slippage
- syringe-recognition-failure
- dosing-error-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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