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 | 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. |
| Product | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 |
| Quantity | 80 total cuffs affected; 4 Boxes of 20 cuffs |
| Distribution | Pakistan |
| Initiated | 2019-06-03 |
| Classified | 2019-08-14 |
| Terminated | 2020-12-16 |
| Recall number | Z-2277-2019 |
| 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-2277-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83070/
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