Model 250D Ambulatory Blood Pressure Monitor labeled under the… — Class II medical device recall Z-0810-2020
Terminated recall by Suntech Medical, Inc., reported 2020-01-22. The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of
| Recall number | Z-0810-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Suntech Medical, Inc., Morrisville, NC, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-01-14 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2023-04-10 |
| Countries outside the US | FR |
| Quantity | 384 units |
| Model numbers | 250D, 99-0233-00, NJ124 |
Product
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
Reason for recall
The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.
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-0810-2020. 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.