Class II — Suntech Medical, Inc.
| Recalling firm | SUNTECH MEDICAL, INC. |
|---|---|
| Registered facility | SUNTECH MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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). |
| Quantity | 384 units |
| Distribution | No US Distribution; Internationally distributed to France, S. America |
| Initiated | 2019-12-11 |
| Classified | 2020-01-14 |
| Terminated | 2023-04-10 |
| Recall number | Z-0810-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Suntech Medical, Inc. (Z-0810-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84531/
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