AVOXimeter 1000E — Class II medical device recall Z-0279-2025
Completed recall by Accriva Diagnostics, Inc., reported 2024-11-06, distributed in AZ. Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may re
| Recall number | Z-0279-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2024-09-27 |
| Classified | 2024-10-31 |
| Reported by FDA | 2024-11-06 |
| Distributed | AZ |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 10711234530023 |
| Serial numbers | 6824 |
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0279-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.