CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
Model 250D Ambulatory Blood Pressure Monitor labeled under recalled
Suntech Medical is recalling Model 250D Ambulatory Blood Pressure Monitor labeled under the. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0810-2020
- FDA event ID
- 84531
- Recalling firm
- Suntech Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2019
- FDA classified
- 14 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 11 Dec 2019 | Recall initiated by company | |
| 14 Jan 2020 | Classified by FDA | +34 days |
| 22 Jan 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
No US Distribution; Internationally distributed to France, S. America
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All serial numbers.
Where was it sold?
No US Distribution; Internationally distributed to France, S. America
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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