Agency classClass IOur severity:Severe FDA (Devices)·Z-1770-2019·Announced 2019-07-17

Becton Dickinson Recalls Alaris Pump Infusion Sets Due to Occlusion Defect

Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.

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: "An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is…"

Plain-English summary

Becton Dickinson & Company is recalling Alaris Pump Infusion Sets due to a defect in the pumping segment. The recall involves 17,992 lots totaling 183,572,651 units, which were distributed worldwide, including nationwide in the United States and in several other countries.

The recall is being issued because a variation in the wall thickness of the pumping segment can cause an incomplete occlusion. This issue has the potential to lead to the unintended delivery of medication when the pump module is not in a running status, or it can result in faster-than-expected drug delivery flow when the pump is infusing.

Healthcare facilities and consumers should check their inventory for the specific model codes and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by Becton Dickinson & Company.

The recalled product

Product: Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion Sets
Hazard: medication-overdose
device-defect

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Same manufacturer · Becton Dickinson & Company

See all →

Severe
BD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
Severe
BD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
Severe
BD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
Severe
BD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10

Same hazard · medication overdose