Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medfusion Syringe Pump Model 4000 Recalled by Smiths Medical ASD Inc. Due to Inaccurate delivery can occur following an interrupted Bolus...
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 Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Quantity: 35616 units
Why Was This Recalled?
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Where Was This Sold?
Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
About Smiths Medical ASD Inc.
Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report