# FDA recall Z-0810-2020

> **Suntech Medical, Inc.** · Class II · device recall initiated 2019-12-11.

## 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.

## Distribution

No US Distribution; Internationally distributed to France, S. America

## Key facts

- **Recall number:** Z-0810-2020
- **Recalling firm:** Suntech Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-11
- **Report date:** 2020-01-22
- **Termination date:** 2023-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2020

## Citation

> AI Analytics. FDA recall Z-0810-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-0810-2020. Source: US FDA. Licensed CC0.

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