94 Million Alaris IV Sets Recalled. The Trouble Zone: Under 1 mL/h

The BD Alaris infusion set recall is more than a year old, but the performance data behind it just changed. BD’s continued testing found that some sets perform worse than the company had told hospitals, mostly at rates under 1 mL/h. FDA posted the update in October, and an FDA recall record tied to it lists 94,230,757 sets in commerce. Some sets are being discontinued. For others, the instructions changed.

What happened: the update, and what is actually new

The background is from 2025. FDA issued an early alert on July 15, 2025, and on Sept. 29, 2025, it announced the issue was a Class I recall, its most serious category. Since then:

• Aug. 19, 2026: BD and its subsidiary CareFusion sent customers an updated letter. FDA says its performance data replaces what BD communicated in its earlier 2025 field action.
• Sept. 15, 2026: FDA’s recall database posted a new record for that action, Z-3080-2026. It lists 94,230,757 in commerce and gives device design as the FDA-determined cause, which FDA notes can change until a recall is terminated.
• Oct. 5, 2026: FDA updated its notice with additional affected products, current recommended actions and updated performance measures.
• Oct. 20, 2026: FDA’s two early alerts, both current as of this date, warn that these sets may be inside Cardinal Health Presource kits.

A note on the numbers: an earlier record, Z-2180-2025, lists 33,162,680 units. FDA lists three recall events and gives no combined total, so we are not adding them together.

The affected products are BD Alaris Pump Infusion Sets compatible with the BD Alaris Pump Module Model 8100, with BD Alaris with Guardrails Suite MX software, versions up to v.12.6. FDA says the concern centers on sets with restrictive components and designs, such as closed male luer, filters, check valves, Y-sites and microbore tubing. In FDA’s words, testing found “the previously claimed performance was overestimated,” and in some instances performance is significantly worse. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of bolus volume.

FDA says that as of Aug. 19, 2026, BD had not reported any serious injuries or deaths associated with this issue.

Why it matters at the bedside

FDA names three potential consequences: greater under- or over-infusion, delayed time to occlusion alarms, and bolus dose inaccuracies. It also warns these may not be readily detected by users, and that users may fail to identify them as the cause of clinically significant changes in a patient’s condition.

The patients at most risk are the ones who most often run at these rates. FDA points to neonates, pediatric patients and critically ill patients, who are more likely to receive lower-rate or lower-volume infusions such as antiarrhythmics or blood-pressure-supporting medications. For them, FDA says, the outcome could be serious adverse events or death.

Norepinephrine shows why small changes in delivery can matter. One current label gives a mean half-life of about 2.4 minutes and calls for blood pressure checks every two minutes until the desired effect is reached, then every five minutes for the rest of the infusion. With a drug that clears that quickly, the patient’s response tells you what the pump display cannot.

What it means for nursing students and the NCLEX

You will not need catalog numbers. You do need the concepts underneath:

• Recall classes. FDA defines Class I as a reasonable chance a product will cause serious health problems or death. A recall does not always mean stop using the product; it can mean check, adjust or relabel it. This one includes both discarding some sets and changing how others are used.
• A quiet pump is not an assessment. A delayed occlusion alarm means silence does not prove the drug is reaching the patient. Assess the patient and the whole line, not only the screen.
• Post-occlusion bolus. FDA’s steps describe excess pressure in an occluded line and the risk of an unintended bolus when it is cleared. That is why flow to the patient must be off first.
• High-alert thinking. ISMP describes high-alert medications as drugs with a heightened risk of significant patient harm when used in error.

What to do now

These steps come from BD’s letter as summarized by FDA. Follow your facility’s process.

• Discontinued sets: identify and discard sets listed in Attachment C of BD’s letter, per facility procedures. Use a clinically appropriate alternate set. If alternates are limited, they go first to critical-care, neonatal, infant and pediatric areas.
• Other affected sets: review the performance disclosures in Attachment B and adjust clinical use, set selection or pump use as needed.
• If performance is not clinically appropriate: use an alternative pump, such as the BD Alaris Syringe Module or another syringe pump. If no syringe pumps are available, the recalled sets may be used with caution, enhanced clinical monitoring and adherence to the warnings already communicated.
• Hang height: do not hang the container below the pump module or more than 21 inches above its top.
• Loading: keep tubing directly over the pressure sensors. Confirm clamps are open, the tubing outside the pump has no kinks or collapses, drops are flowing in the drip chamber, and the vent is open if applicable.
• Pressure setting: do not use Selectable pressure mode above 50 mmHg for rates under 10 mL/h.
• Clearing an occlusion: make sure flow to the patient is off. Disconnect the tubing to relieve excess pressure through a stopcock if present, weighing the risks of disconnection against the risks of an unintended bolus.
• Presource kits: FDA has two separate alerts with separate lists. Under one, kits are quarantined and labeled so clinicians remove and discard the recalled component. Under the other, customers follow BD’s performance and use instructions. Check which applies before opening a kit.
• Report problems through your facility and to FDA MedWatch. BD Technical Support is at 866-488-1408.