Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
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: FDA Class I classification requires a minimum severity score of 4. The recalled pump models have multiple failures affecting critical alarm systems and infusion delivery that could cause therapy interruption or dangerous over-infusion of medications. Although no illnesses or deaths are reported in the source text, the potential for serious patient harm from these failures justifies the Severe classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medfusion Syringe Pump (11 models) due to multiple issues that could interrupt medication delivery or cause over-infusion. The affected models are: 4000-0100-50, 4000-0101-249, 4000-0101-50, 4000-0101-51, 4000-0101-78, 4000-0105-249, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. A total of 58,671 units have been distributed worldwide, including throughout the United States and 41 other countries.
The recalled pumps have been identified with eight separate issues: failure of the Primary Audible Alarm, unanticipated depleted battery alarms, time base alarm malfunctions, intermittent infusion continuation after system failure, clearing of the programmed volume delivered, false alarms for rates below recommended minimums, incorrect bolus or loading dose time displays, and a DNS port communication issue. These failures could result in unintended interruption of therapy or uncontrolled over-infusion of medication.
Healthcare facilities and users in possession of these syringe pumps should immediately stop using affected units and contact Smiths Medical ASD Inc. for instructions. Facilities should verify whether they have any of the recalled models by checking serial numbers against the manufacturer's notification and cease use pending further guidance.
The recalled product
- Product
- Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- therapy-interruption
- over-infusion
- alarm-failure
- display-error
- software-issue
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 4000-0100-50: UDI 061058603532
- Serial Numbers: 2000380
- 2000342
- 2000351
- 2000485
- 2002080
- 2000501
- 2000275
- 2002089
- 2000528
- 2000386
- 2002086
- 2000555
- 2002083
- 2000530
- 2000495
- 2002084
- 2002087
- 2000452
- 2002092
Distribution
Distributed nationwide across the United States.
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