Agency classClass IOur severity:Severe FDA (Devices)·Z-3080-2026·Announced 2026-09-23

BD Alaris Pump Infusion Sets Recalled for Performance Data Discrepancies

BD Switzerland is recalling BD Alaris Pump Infusion Sets due to discrepancies in performance data that may lead to inappropriate pump performance.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance."

Plain-English summary

BD Switzerland SARL is recalling specific lots of BD Alaris Pump Infusion Sets. The recall was initiated due to discrepancies in specific attributes within the performance data for these infusion sets.

These discrepancies may lead to inappropriate pump performance. The affected products include various models of BD Alaris Pump Infusion Sets and Blood Sets, distributed nationwide in the United States and in numerous international markets.

Healthcare facilities and consumers should stop using the affected infusion sets and contact BD Switzerland for further instructions or replacement.

The recalled product

Product: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back…
Manufacturer: BD SWITZERLAND SARL
Category: Medical Device — Infusion Sets
Hazard: performance-defect
Affected units: 94,230,757

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)

10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set
15 Micron Filter
Back Check Valve
SmartSite Bag Access Non-Vented
PE Lined Tubing
2 Back Check Valves
180 Micron Filter
Bonded Texium
Closed Male Luer with Priming Cap
0.2 Micron Filter
Bonded Texium Closed Male Luer with Priming Cap
1.2 Micron Filter
Smallbore Tubing
SmartSite Port (Burette)
Manifold
3-Way Stopcock
2 Ganged 4-Way Stopcocks
3 Ganged 4-Way Stopcocks
Vented Syringe Adapter
Bonded Texium Closed Male

Distribution

Distributed in 54 states:

Same manufacturer · BD SWITZERLAND SARL

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Same hazard · performance defect