Suntech Medical, Inc.
Suntech Medical, Inc. has 3 FDA enforcement events on this register (3 product records) between 2019 and 2020: 3 device; the busiest year was 2019 with 2.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in NC.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 20 Apr 2020 | Oscar 2, Model 250 System | Device | Class II | 1 | Terminated |
| 11 Dec 2019 | 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). | Device | Class II | 1 | Terminated |
| 3 Jun 2019 | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Suntech Medical, Inc. had?
3 enforcement events (3 product records) on this register, 2019–2020: 3 device.
Are any Suntech Medical, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Suntech Medical, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.