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The FDA says BD and CareFusion updated a recall involving certain BD Alaris Pump Infusion Sets used with the Alaris Pump Module 8100. The agency identifies it as its most serious recall category; BD says updated testing found some sets may perform worse than previously disclosed, particularly in certain low-rate or low-volume situations. No serious injuries or deaths had been reported to BD as of August 19, 2026.
BD and CareFusion 303, Inc. have updated a recall of certain BD Alaris Pump Infusion Sets, telling affected health care customers to discard discontinued sets and review new performance information. The FDA identifies the action as a Class I recall, its most serious category, because continued use of an affected device may cause serious injury or death.
The affected sets are compatible with the BD Alaris Pump Module Model 8100 and Alaris software with Guardrails Suite MX, versions up to 12.6, according to the FDA. The agency says the updated letter replaces performance information previously communicated by BD in field action MMS-25-5311. Customers should consult the FDA’s affected-product information and BD’s letter to identify the specific sets covered.
BD said further testing found that its earlier performance estimates for some infusion sets had been overestimated. Sets with restrictive components or designs—including closed male luer connectors, filters, check valves, Y-sites and microbore tubing—may perform worse than previously disclosed. BD says deviations occur most often at programmable rates below 1 mL per hour and at or below 5 mL of bolus volume.
The potential performance differences include more under-infusion or over-infusion than expected, delayed occlusion alarms and inaccurate bolus doses. The FDA says these issues may be difficult for users to recognize as the cause of a change in a patient’s condition. BD reported no serious injuries or deaths associated with the issue as of August 19, 2026.
Risks for Patients on Precise Infusions
Infusion pumps deliver medication and fluids at programmed rates, so differences between expected and actual delivery can matter clinically. The FDA says the possible outcomes depend on the circumstances and patient, and points to neonatal, pediatric and critically ill patients as higher-risk groups. These patients are more likely to receive low-rate or low-volume infusions, including medications used to manage heart rhythm or support blood pressure.
The recall matters to hospitals and other care providers because the updated instructions may require them to locate and remove specified sets, choose clinically suitable alternatives, and review how they use the pump. If a set performs differently than expected, a clinician might not immediately identify the pump-and-set performance as the reason for a change in a patient’s condition. The FDA’s warning describes a potential risk; it does not establish that a particular patient has been harmed.
Facilities may also face supply constraints. BD and the FDA advise prioritizing available alternate sets for critical-care, neonatal, infant and pediatric areas when quantities are limited. For care teams, the practical issue is matching the set and pump to the clinical use while following the revised risk-mitigation guidance.
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What the Updated Recall Covers
The Alaris System is a modular infusion pump and monitoring system used to administer fluids continuously or intermittently to adult, pediatric and neonatal patients. The FDA says it can be used through routes including intravenous, intra-arterial, subcutaneous and epidural administration, as well as irrigation of fluid spaces. The recall concerns certain infusion sets used with the Model 8100 pump module, not a general statement that every Alaris product is affected.
In its August 19, 2026, customer letter, BD updated its disclosures after continued testing of infusion-set performance. The FDA says the new performance information replaces material in the earlier field action. The updated action combines two issues for customers: certain sets are discontinued and must be removed, while performance disclosures for identified sets call for review of clinical use, set selection or pump use.
The FDA directs customers to BD’s letter and the affected-product spreadsheet for set-specific information. Because the product list distinguishes discontinued sets, users should not assume that every set compatible with the pump has the same status or performance characteristics.
“The previously claimed performance was overestimated.”
— BD, as summarized by the FDA
infusion set replacement for Alaris Pump
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Set-Specific Risks and Patient Effects
The FDA’s materials do not establish how often the performance differences occur across all affected sets or what impact they have had in individual cases. BD’s reported absence of serious injuries or deaths is limited to information available as of August 19, 2026; it does not establish that no other adverse effects occurred or that future risk has ended.
The exact sets affected, their performance disclosures and whether a set is discontinued must be checked against BD’s customer letter and the FDA product list. The risk also depends on factors such as the set design, programmed rate, delivered volume and patient. The available information does not identify how many facilities have completed the recommended review or how many sets remain in use.
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Facility Actions and Ongoing Monitoring
Facilities should identify and discard sets listed as discontinued in Attachment C of BD’s letter, following their internal procedures. They should select an alternative set that is clinically appropriate for the specific use, review the performance disclosures in Attachment B, and adjust set selection or pump use where needed. If alternatives are limited, the FDA says facilities should prioritize them for critical-care, neonatal, infant and pediatric areas.
BD and the FDA also advise considering an alternative pump if performance with an identified set is not clinically appropriate. The letter says that if no syringe pump is available, recalled sets may be used with caution, enhanced clinical monitoring and adherence to previously communicated warnings. Care teams should follow the current BD customer letter and applicable facility procedures rather than relying on this article for device-specific decisions.
For continued use under the stated risk-mitigation guidance, the FDA lists steps including keeping the solution container at the recommended height, positioning tubing directly over pressure sensors when loading the set, and checking that clamps are open, tubing is not kinked and drops are flowing. It also describes precautions for occlusion alarms and clearing, including stopping fluid flow to the patient and weighing the risks of disconnection against an unintended bolus. The FDA’s recall page and BD’s letter are the sources for updated instructions as the action develops.
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Key Questions
Which products are included in the recall?
The recall covers certain BD Alaris Pump Infusion Sets compatible with the Alaris Pump Module Model 8100, with Alaris Guardrails Suite MX software versions up to 12.6 listed in the FDA notice. Check the FDA affected-product information and BD’s letter for the specific set identifiers and discontinued products.
Why did BD update the performance information?
BD said continued testing found that earlier performance estimates for some sets were overestimated. The FDA says the updated disclosures replace information in an earlier BD field action and address the possibility of under- or over-infusion, delayed occlusion alarms and inaccurate bolus doses.
What should health care facilities do with discontinued sets?
The FDA says facilities should identify and discard the sets listed as discontinued in BD’s customer letter, then use a clinically appropriate alternative for the particular care need. Where alternatives are limited, the agency says to prioritize them for critical-care, neonatal, infant and pediatric areas.
Have serious injuries or deaths been reported?
The FDA says BD had reported no serious injuries or deaths as of August 19, 2026. That statement reflects the reported status on that date and does not mean the potential risk described in the recall has been eliminated.
Source: primary
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