Oscar 2 — Class II medical device recall Z-2429-2020
Terminated recall by Suntech Medical, Inc., reported 2020-07-01, distributed nationwide. The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a t
| Recall number | Z-2429-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Suntech Medical, Inc., Morrisville, NC, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-06-25 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2023-06-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BM, BR, CA, CZ, DO, EE, ES, FR, GB, HR, IE, IN, LB, LV, MA, PE, PK, PL, SA, SG, TW, VN, ZA |
| Quantity | 1,037 units |
| Serial numbers | 99-0133-00, 99-0133-01, 99-0133-02, 99-0133-03, 99-0133-10, 99-0133-22, 99-0133-40 |
| Model numbers | 250, 99-0133-00, 99-0133-01, 99-0133-02, 99-0133-03, 99-0133-10, 99-0133-22, 99-0133-40 |
Product
Oscar 2, Model 250 System
Reason for recall
The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
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-2429-2020. 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.