AVSM3 SNF — Class II medical device recall Z-2096-2021
Terminated recall by Mediana Co., Ltd., reported 2021-07-28, distributed in WI. In some cases the equipment fails to power up and/or key or button unresponsive or not working.
| Recall number | Z-2096-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mediana Co., Ltd., Wonju, N/A, Korea (the Republic of) |
| Recall initiated | 2021-05-17 |
| Classified | 2021-07-19 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-11-04 |
| Distributed | WI |
| Quantity | 618 |
| UPC / GTIN / UDI-DI | 00460062000002, 18800003460066 |
| Serial numbers | 460062000002 |
Product
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Reason for recall
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
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-2096-2021. 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.