FDA Device recall Z-0810-2020
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00 by Suntech Medical, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-11 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Suntech Medical |
| Distribution | n/a |
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
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.
Identifiers
| code_info | All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2020%22
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