RegWardenFDA facility compliance records
Company

SUNTECH MEDICAL, INC.

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2019: 2 recalls; 2020: 1 recalls201720182201912020202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2020-04-20
    The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
  • Class IITerminated2019-12-11
    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.
  • Class IITerminated2019-06-03
    Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SUNTECH MEDICAL, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1036863-suntech-medical-inc/

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