The Recall Desk
Agency classClass IIOur severity:Severity pendingFDA (Devices)·Z-0160-2027·Announced 2026-10-21

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513

The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance…

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.

The recalled product

Product
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Devices
Affected units
2,088

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 (2)

  • Product/UDI-DI: DxU 840m/15099590748654
  • DxU 850m/15099590748647. All Serial Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Related recalls

Same manufacturer · Beckman Coulter, Inc.

See all →