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BD recalled certain infusion sets used with the Alaris Pump Module 8100 after its testing showed performance could differ from the user manual, and in 2026 disclosed that some sets perform worse than previously stated. FDA identifies the recall as Class I, the most serious type.
TierThe sources document a recall and revised performance disclosures while pumps stayed in use; no loss of automation or switch to manual infusion is documented. How tiers are assigned.
FDA's notice lists an Early Alert on 15 July 2025 for certain BD Alaris pump infusion sets used with the Alaris Pump Module model 8100 and classification as a Class I recall on 29 September 2025; Medical Daily gives 17 July 2025 for the Early Alert and 29 September 2026 for the classification. In a September 2025 update published by FDA, BD added 15 more sets to the recall, said it had received no complaints associated with the issue, and noted a higher risk to vulnerable patients such as neonates and the critically ill. On 19 August 2026 BD and CareFusion 303 sent customers an urgent medical device correction. FDA's recall record Z-3080-2026 gives the reason as 'discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance', a cause of device design, and 94,230,757 units in commerce; Medical Daily reported that FDA's database lists 33,162,680 affected units, and the sources do not reconcile the two figures. In FDA's 5 October 2026 update, BD stated that some sets with restrictive components and designs 'perform worse than previously disclosed', most commonly at programmed rates under 1 mL/h and bolus volumes of 5 mL or less, and that previously claimed performance was overestimated. FDA relays BD's advice to discard listed discontinued sets, prioritise alternative sets in critical-care, neonatal, infant and paediatric areas, and use a syringe pump where set performance is not clinically appropriate. Medical Daily reported that BD had not publicly explained how the discrepancy was found beyond continued testing.[1,2,3,4]
None documented; according to FDA, as of 19 August 2026 BD had not reported any serious injuries or deaths associated with the issue.
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