FDA Medical Device Recalls (openFDA)
Suntech Medical, Inc.: 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).
- Recall number
- Z-0810-2020
- Recalling firm
- Suntech Medical, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2019-12-11
- Posted
- not on file
- Terminated
- 2023-04-10
- 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.
- Root cause
- Device Design
- Action
- Consignees notified via email with recall letter dated 12/11/2019. The letter identified affected product, stated reason for recall, and requested product not to be used, and to be returned to the distributor. A Recall Acknowledgement Form was requested to be returned by e-mail.
- Quantity
- 384 units
- Distribution
- No US Distribution; Internationally distributed to France, S. America
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K151520"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 1036863
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28