Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical drug-infusion device. Per FDA classification, Class I recalls indicate potential for serious adverse health consequences. The identified defects—including failure of protective alarms and potential for uncontrolled infusion—pose significant risk during medication administration.
Plain-English summary
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Models 3500 and numerous variants (with software versions 6.0.0 and 6.0.1). This Class I recall addresses eight distinct defects with potential for interruption of drug therapy or over-infusion of medication.
The identified defects include: failures of the primary audible alarm; unanticipated battery depletion alerts; time base alarm errors; continued infusion after system failure; clearing of delivered volume data; false rate alarms; incorrect bolus time displays; and DNS port issues. These malfunctions may prevent critical safety alarms from alerting clinicians or may cause unintended over-infusion of medication to patients.
Approximately 65,093 units have been distributed worldwide, including throughout the United States, US Virgin Islands, and multiple international locations. Patients depending on affected pumps for critical drug infusion therapy are potentially at risk.
Discontinue use of affected Medfusion Pump models immediately. Healthcare facilities should contact Smiths Medical ASD Inc. for device replacement or repair options. The FDA recall number for this action is Z-1272-2022.
The recalled product
- Product
- Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- over-infusion
- alarm-system-failure
- therapy-interruption
- device-malfunction
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)
- Model 3500: No UDI
- Serial Numbers: Model 3500: No UDI
- Serial Numbers: M63658
- M36749
- M16998
- M31819
- M62715
- M62716
- M29795
- M21251
- M32302
- M31248
- M31839
- M29543
- M22299
- M34554
- M29749
- M22179
- M25875
- M21234
Distribution
Distributed nationwide across the United States.
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