The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2179-2025·Announced 2025-08-13

BD Alaris pump modules may perform outside established flow rate ranges

BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

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: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The BD Alaris Pump Module Model 8100 with Guardrails Suite MX software versions is being recalled across all serial numbers. The source states a total of 33,162,680 units.

The stated reason is that the infusion pump module, used with compatible pump infusion sets, may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States across all states and territories listed in the recall notice. The pump modules are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the model number and UDI codes above and follow the instructions issued by BD.

The recalled product

Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion pump
Hazard
Affected units
33,162,680

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 (5)

  • BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054
  • 10885403517723
  • 10885403810015
  • 10885403810039
  • 10885403810046

Distribution

Distributed nationwide across the United States.

The notice also names 55 states specifically:

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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