Morrisville, NC, United States
Suntech Medical, Inc. recalls
3 recalls recorded since 2018, most recently on 20 April 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 April 2020
- Terminated
- 13 June 2023
- Reason
- 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.
- Distribution
- Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2429-2020
- Oscar 2, Model 250 System
Terminated Class II Medical devices
- Recall started
- 11 December 2019
- Terminated
- 10 April 2023
- 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.
- Distribution
- No US Distribution; Internationally distributed to France, S. America
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0810-2020
- 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).
Terminated Class II Medical devices
- Recall started
- 3 June 2019
- Terminated
- 16 December 2020
- Reason
- 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.
- Distribution
- Pakistan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2277-2019
- SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.