Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medfusion Model 3500 Syringe Pump Recalled by Smiths Medical ASD, Inc. Due to An issue with the plunger rod seal was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.
Affected Products
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Quantity: 6
Why Was This Recalled?
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Where Was This Sold?
This product was distributed to 1 state: NH
About Smiths Medical ASD, Inc.
Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report