Accriva Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0279-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

Product Classification:

Class II

Date Initiated: September 27, 2024

Date Posted: November 6, 2024

Recall Number: Z-0279-2025

Event ID: 95497

Reason for Recall:

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

Status: Completed

Product Quantity: 1

Code Information:

UDI-DI: 10711234530023. Serial Number: 6824

Distribution Pattern:

US: AZ

Voluntary or Mandated:

Voluntary: Firm initiated