DIRECT SUPPLY Attendant VITAL SIGNS MONITOR — Class II medical device recall Z-2441-2020
Terminated recall by Mediana Co., Ltd., reported 2020-07-08, distributed nationwide. Failures were found in the temperature measurement function while in the predict mode.
| Recall number | Z-2441-2020 |
|---|---|
| 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 | 2020-05-15 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 180 devices |
| UPC / GTIN / UDI-DI | 00456802000180 |
| Model numbers | AVSM2 |
Product
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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
Failures were found in the temperature measurement function while in the predict mode.
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-2441-2020. 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.